How to get ventolin online

asthma treatment has evolved how to get ventolin online rapidly into a ventolin with global impacts. However, as the ventolin has developed, it has become increasingly evident that the risks of asthma treatment, both in terms of how to get ventolin online rates and particularly of severe complications, are not equal across all members of society. While general risk factors for hospital admission with asthma treatment include age, male sex and specific comorbidities (eg, cardiovascular disease, hypertension and diabetes), there is increasing evidence that people identifying with Black, Asian and Minority Ethnic (BAME) groupsi have disproportionately higher risks of being adversely affected by asthma treatment in the UK and the USA. The ethnic disparities include overall numbers of cases, as well as how to get ventolin online the relative numbers of critical care admissions and deaths.1In the area of mental health, for people from BAME groups, even before the current ventolin there were already significant mental health inequalities.2 These inequalities have been increased by the ventolin in several ways. The constraints of quarantine have made access to traditional face-to-face support from mental health services more difficult in general.

This difficulty will increase how to get ventolin online pre-existing inequalities where there are challenges to engaging people in care and in providing early access to services. The restrictions may also reduce the flexibility of care offers, given the need for social isolation, limiting non-essential travel and closure of routine clinics. The service impacts are compounded by constraints on the use of non-traditional or alternative routes to care and support.In addition, there is growing evidence of specific mental health consequences from significant asthma treatment how to get ventolin online , with increased rates of not only post-traumatic stress disorder, anxiety and depression, but also specific neuropsychiatric symptoms.3 Given the higher risks of mental illnesses and complex care needs among ethnic minorities and also in deprived inner city areas, asthma treatment seems to deliver a double blow. Physical and mental health vulnerabilities are inextricably linked, especially as a significant proportion of healthcare workers (including in mental health services) in the UK are from BAME groups.Focusing on mental health, there is very little asthma treatment-specific guidance on the needs of patients in the BAME group. The risk to staff in general healthcare (including mental healthcare) is a particular concern, and in response, the Royal College of Psychiatrists and NHS England have produced a report on the impact of asthma treatment on how to get ventolin online BAME staff in mental healthcare settings, with guidance on assessment and management of risk using an associated risk assessment tool for staff.4 5However, there is little formal guidance for the busy clinician in balancing different risks for individual mental health patients and treating appropriately.

Thus, for example, an inpatient clinician may want to know whether a patient who is older, has additional comorbidities and is from an ethnic background, should be started on one antipsychotic medication or another, or whether treatments such as vitamin D prophylaxis or treatment and venous thromboembolism prevention should be started earlier in the context of the asthma treatment ventolin. While syntheses of the existing guidelines are available about asthma treatment and mental health,6 7 there is nothing specific about the healthcare needs of patients from ethnic how to get ventolin online minorities during the ventolin.To fill this gap, we propose three core actions that may help:Ensure good information and psychoeducation packages are made available to those with English as a second language, and ensure health beliefs and knowledge are based on the best evidence available. Address culturally grounded explanatory models and illness perceptions to how to get ventolin online allay fears and worry, and ensure timely access to testing and care if needed.Maintain levels of service, flexibility in care packages, and personal relationships with patients and carers from ethnic minority backgrounds in order to continue existing care and to identify changes needed to respond to worsening of mental health.Consider modifications to existing interventions such as psychological therapies and pharmacotherapy. Have a high index of suspicion to take into account emerging physical health problems and the greater risk of serious consequences of asthma treatment in ethnic minority people with pre-existing chronic conditions and vulnerability factors.These actions are based on clinical common sense, but guidance in this area should be provided on the basis of good evidence. There has already been a call for urgent research in the area of asthma treatment and mental health8 how to get ventolin online and also a clear need for specific research focusing on the post-asthma treatment mental health needs of people from the BAME group.

Research also needs to recognise the diverse range of different people, with different needs and vulnerabilities, who are grouped under the multidimensional term BAME, including people from different generations, first-time migrants, people from Africa, India, the Caribbean and, more recently, migrants from Eastern Europe. Application of a race equality impact assessment to all research questions and methodology has recently been proposed as a first step in how to get ventolin online this process.2 At this early stage, the guidance for assessing risks of asthma treatment for health professionals is also useful for patients, until more refined decision support and prediction tools are developed. A recent Public Health England report on ethnic minorities and asthma treatment9 recommends better recording of ethnicity data in health and social care, and goes further to suggest this should also apply to death certificates. Furthermore, the report recommends more participatory and experience-based research to understand causes and consequences of pre-existing multimorbidity and asthma treatment , integrated care systems that work well for susceptible and marginalised groups, culturally competent health promotion, prevention and occupational risk assessments, and recovery strategies to mitigate the risks of widening inequalities as we come out of restrictions.Primary data collection will need to cover not only hospital admissions but also data from primary care, linking information on mental health, how to get ventolin online asthma treatment and ethnicity. We already have research and specific guidance emerging on other risk factors, such as age and gender.

Now we also need to focus on an equally important aspect of vulnerability how to get ventolin online. As clinicians, we need to balance the relative risks for each of our patients, so that we can act promptly and proactively in response to their individual needs.10 For this, we need evidence-based guidance to ensure we are balancing every risk appropriately and without bias.Footnotei While we have used the term ‘people identifying with BAME groups’, we recognise that this is a multidimensional group and includes vast differences in culture, identity, heritage and histories contained within this abbreviated term..

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Health researchers from Mathematica will, como funciona el ventolin for http://bacma.co.uk/uncategorized/hello-world/ the second consecutive year, virtually attend AcademyHealth’s Annual Research Meeting taking place June 14 to 17. Our team will present their latest insights on a diverse range of topics in behavioral health, long-term care, and primary care. We will como funciona el ventolin also participate in live and on-demand sessions to discuss our research and its policy implications.The following are some notable sessions from Mathematica at the Annual Research Meeting:Access to Care for People with Mental Health and Substance Use Disorders During the asthma treatment ventolin. Melissa Azur will chair a session highlighting how policy changes to promote continuity of mental health care (such as telehealth) have varied widely across states and have unevenly benefited different patient groups, including minority populations.Why Dually Eligible Beneficiaries Stay or Leave Integrated Care Plans. Authors Danielle Chelminsky, Debra Lipson, and Laura Kimmey discuss their research como funciona el ventolin on the need for improved integrated plans across Medicare and Medicaid to increase member retention.

Emerging Evidence on the Impact of asthma treatment in Long-Term Care. Mathematica’s Patricia Rowan, Debra como funciona el ventolin Lipson, Michael Levere, and Noelle Denny-Brown review their research on the impact of asthma treatment in nursing homes, including the effects of the ventolin on the long-term care workforce. They will also examine strategies employed by facilities and government agencies in other states to support and strengthen the long-term care workforce during the early phase of the outbreak.Check out an agenda of all our activities at the 2021 Annual Research Meeting. Conference attendees are encouraged to visit our virtual booth in the exhibit hall to learn more about our work, sign up for our newsletters, and como funciona el ventolin chat live with staff. Follow us on Twitter for more updates.NewWave, a full-service Information Technology (IT), business services, and data management company, together with Mathematica, the national Medicaid expert and an insight partner to public and private-sector changemakers, announced today that they will partner with the Maryland Department of Health to implement Imersis, their cloud-based data quality tool.

Imersis will allow the Maryland Department como funciona el ventolin of Health to dive deep, explore, and refine their Transformed Medicaid Information System (T-MSIS) data. Built on cloud-first architecture, Imersis is a leading-edge Software-as-a-Service (SaaS) which scores files against similar data quality measures as the Centers for Medicare and Medicaid Services (CMS). Imersis decomposes como funciona el ventolin T-MSIS Top Priority Items (TPIs) into data quality measures and allows users to pinpoint specific issues, root out the sources of bad data, and remediate low scores before submitting data files to CMS. NewWave and Mathematica, drawing on their combined extensive experience working with the CMS and their deep knowledge of Medicaid data, are a uniquely suited partnership to support the Maryland Department of Health and improve the data quality of its Medicaid program. €œThe Imersis tool provides a way for states to como funciona el ventolin visualize their Medicaid data quality and build a strong data analytics program,” said Jay Tanner, NewWave Program Director for Imersis.

€œImersis leverages a secure cloud environment and leads with human-centered design (HCD) principles which enables us to ingest T-MSIS data, score it against CMS’s list of Top Priority Items (TPIs), see the scores before submitting to CMS, and make improvements in those areas.” “Imersis is the product of a collaboration which will provide a way for states to leverage advanced data quality analytics and reporting,” said Paul Messino, Senior Researcher and Director of Mathematica’s State Medicaid work. €œI am excited for this opportunity for Mathematica and NewWave to help the Maryland T-MSIS team configure and use Imersis to improve Medicaid data quality for Maryland.” “We view T-MSIS as como funciona el ventolin one of the most important projects which aims to improve data quality and realize better health outcomes through customer service and program integrity - a vision the Department shares with CMS,” said David Wertheimer, Enterprise Architect with the Maryland Department of Health. €œBoth Mathematica and NewWave have demonstrated unparalleled expertise and leadership in T-MSIS and data quality reporting, and we are thrilled to partner with them on this project.”To learn more about Imersis, please visit www.mathematica.org/toolkits/imersis.ContactSarah RodriguezEmail. Sarah.rodriguez@newwave.io Todd Kohlhepp como funciona el ventolin Email. Tkohlhepp@mathematica-mpr.com.

Health researchers from Mathematica will, for the second consecutive year, virtually attend AcademyHealth’s Annual Research Meeting taking place June 14 to how to get ventolin online can i get ventolin over the counter 17. Our team will present their latest insights on a diverse range of topics in behavioral health, long-term care, and primary care. We will also participate in live and on-demand sessions to discuss our research and its policy implications.The following are some notable sessions from Mathematica at the Annual Research Meeting:Access to Care for People with Mental Health and Substance Use how to get ventolin online Disorders During the asthma treatment ventolin. Melissa Azur will chair a session highlighting how policy changes to promote continuity of mental health care (such as telehealth) have varied widely across states and have unevenly benefited different patient groups, including minority populations.Why Dually Eligible Beneficiaries Stay or Leave Integrated Care Plans. Authors Danielle Chelminsky, Debra Lipson, and Laura Kimmey discuss their research on the need for improved integrated plans across how to get ventolin online Medicare and Medicaid to increase member retention.

Emerging Evidence on the Impact of asthma treatment in Long-Term Care. Mathematica’s Patricia Rowan, Debra Lipson, Michael Levere, and Noelle Denny-Brown how to get ventolin online review their research on the impact of asthma treatment in nursing homes, including the effects of the ventolin on the long-term care workforce. They will also examine strategies employed by facilities and government agencies in other states to support and strengthen the long-term care workforce during the early phase of the outbreak.Check out an agenda of all our activities at the 2021 Annual Research Meeting. Conference attendees are encouraged to visit our virtual booth in the exhibit hall to learn more about our work, sign how to get ventolin online up for our newsletters, and chat live with staff. Follow us on Twitter for more updates.NewWave, a full-service Information Technology (IT), business services, and data management company, together with Mathematica, the national Medicaid expert and an insight partner to public and private-sector changemakers, announced today that they will partner with the Maryland Department of Health to implement Imersis, their cloud-based data quality tool.

Imersis will allow the Maryland Department of how to get ventolin online Health to dive deep, explore, and refine their Transformed Medicaid Information System (T-MSIS) data. Built on cloud-first architecture, Imersis is a leading-edge Software-as-a-Service (SaaS) which scores files against similar data quality measures as the Centers for Medicare and Medicaid Services (CMS). Imersis decomposes T-MSIS Top Priority Items (TPIs) into data quality measures and allows users to pinpoint specific issues, root out the sources of bad data, and remediate low scores before submitting data how to get ventolin online files to CMS. NewWave and Mathematica, drawing on their combined extensive experience working with the CMS and their deep knowledge of Medicaid data, are a uniquely suited partnership to support the Maryland Department of Health and improve the data quality of its Medicaid program. €œThe Imersis tool provides a way for states how to get ventolin online to visualize their Medicaid data quality and build a strong data analytics program,” said Jay Tanner, NewWave Program Director for Imersis.

€œImersis leverages a secure cloud environment and leads with human-centered design (HCD) principles which enables us to ingest T-MSIS data, score it against CMS’s list of Top Priority Items (TPIs), see the scores before submitting to CMS, and make improvements in those areas.” “Imersis is the product of a collaboration which will provide a way for states to leverage advanced data quality analytics and reporting,” said Paul Messino, Senior Researcher and Director of Mathematica’s State Medicaid work. €œI am excited for this opportunity for Mathematica and NewWave to help the Maryland T-MSIS team configure and use Imersis to improve Medicaid data quality for Maryland.” “We view T-MSIS as one of the most important projects which aims to improve data quality and realize better health outcomes through how to get ventolin online customer service and program integrity - a vision the Department shares with CMS,” said David Wertheimer, Enterprise Architect with the Maryland Department of Health. €œBoth Mathematica and NewWave have demonstrated unparalleled expertise and leadership in T-MSIS and data quality reporting, and we are thrilled to partner with them on this project.”To learn more about Imersis, please visit www.mathematica.org/toolkits/imersis.ContactSarah RodriguezEmail. Sarah.rodriguez@newwave.io Todd Kohlhepp Email how to get ventolin online. Tkohlhepp@mathematica-mpr.com.

What should I tell my health care providers before I take Ventolin?

They need to know if you have any of the following conditions:

• diabetes
• heart disease or irregular heartbeat
• high blood pressure
• pheochromocytoma
• seizures
• thyroid disease
• an unusual or allergic reaction to albuterol, levalbuterol, sulfites, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

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5-Aminolevulinic acid Antineoplastic agents 234673 2020-03 2020-09 Issued Notice of Compliance Abemaciclib Antineoplastic agents 215268 2018-06 2019-04 Issued Notice of Compliance Acalabrutinib Antineoplastic agents 214504 2018-04 2019-08 Issued Notice of Compliance Acetaminophen Analgesics 209478 2018-02 2018-11 Issued Notice of Compliance Adalimumab Immunosuppressants 203250 2017-04 2018-05 Issued Notice of Compliance Adalimumab Immunosuppressants 203292 2017-04 2018-05 Issued Notice of Compliance Adalimumab Immunosuppressants 230637 2019-10 2020-10 Issued Notice of Compliance Adalimumab Immunosuppressants 217314 2018-11 2020-11 Issued Notice of Compliance Adalimumab Immunosuppressants 229124 2019-09 2020-11 Issued Notice of Compliance Alectinib Antineoplastic agents 189442 2016-02 2016-09 Issued Notice of Compliance under the NOC/c Guidance Alirocumab Lipid modifying agents 183116 2015-06 2016-04 Issued Notice of Compliance Alpelisib Antineoplastic agents 226941 2019-05 2020-03 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B-domain deleted, pegylated) Antihemorrhagics 210935 2017-12 2018-10 Issued Notice of Compliance Antihemophilic factor VIII (Recombinant, B-domain truncated), pegylated Antihemorrhagics 218531 2018-09 2019-07 Issued Notice of Compliance Apalutamide Endocrine therapy 211942 2018-01 2018-07 Issued Notice of Compliance Apomorphine hydrochloride Anti-parkinson drugs 217320 2018-08 2020-06 Issued Notice of Compliance Ataluren Other drugs for disorders of the musculo-skeletal system 186992 2015-09 2016-03 Cancelled by sponsor Ataluren Other drugs for disorders of the musculo-skeletal system 217349 2018-09 2019-10 Cancelled by sponsor Atezolizumab Antineoplastic agents 196843 2016-08 2017-04 Issued Notice of Compliance under the NOC/c Guidance Avelumab Antineoplastic agents 204052 2017-04 2017-12 Issued Notice of Compliance under the NOC/c Guidance Avelumab Antineoplastic agents 208742 2017-09 2018-05 Issued Notice of Compliance under the NOC/c Guidance Axicabtagene ciloleucel Antineoplastic agents 218389 2018-08 2019-02 Issued Notice of Compliance Bacillus Calmette-Guerin BCG - Strain Russian BCG-I Immunostimulants 221579 2018-12 2020-12 Issued Notice of Compliance under the NOC/c Guidance Baloxavir marboxil Antivirals for systemic use 227361 2019-05 2020-02 Issued Notice of Compliance Baricitinib Antiinflammatory and antirheumatic products 193687 2016-05 2018-08 Issued Notice of Compliance Belinostat Antineoplastic agents 208886 2017-12 2019-11 Cancelled by sponsor Benralizumab Immunosuppressants 204008 2017-04 2018-02 Issued Notice of Compliance Bepotastine besilate Ophthalmologicals 179294 2015-10 2016-07 Issued Notice of Compliance Betamethasone valerate, fusidic acid Corticosteroids, dermatological preparations 203765 2017-06 2018-04 Issued Notice of Compliance Betula verrucosa extract Nasal preparations 227270 2019-06 2020-04 Issued Notice of Compliance Bevacizumab Antineoplastic agents 201427 2017-02 2018-04 Issued Notice of Compliance Bevacizumab Antineoplastic agents 218183 2018-08 2019-06 Issued Notice of Compliance Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 203718 2017-09 2018-07 Issued Notice of Compliance Bilastine Antihistamines for systemic use 184231 2015-06 2016-04 Issued Notice of Compliance Bisoprolol fumarate Beta blocking agents 203050 2017-07 2019-11 Issued Notice of Compliance Bisoprolol fumarate Beta blocking agents 231842 2020-05 2020-09 Cancelled by sponsor Bivalirudin Antithrombotic agents 232423 2019-11 2020-09 Issued Notice of Compliance Blinatumomab Antineoplastic agents 181723 2015-04 2015-12 Issued Notice of Compliance under the NOC/c Guidance Botulinum antitoxin, serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins 190645 2016-02 2016-12 Issued Notice of Compliance Brexpiprazole Psycholeptics 192684 2016-04 2017-02 Issued Notice of Compliance Brigatinib Antineoplastic agents 210369 2017-11 2018-07 Issued Notice of Compliance under the NOC/c Guidance Brivaracetam Antiepileptics 183355 2015-05 2016-03 Issued Notice of Compliance Brodalumab Immunosuppressants 195317 2016-07 2018-03 Issued Notice of Compliance Brolucizumab Ophthalmologicals 226224 2019-05 2020-03 Issued Notice of Compliance Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 227232 2019-05 2019-11 Issued Notice of Compliance Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 220876 2019-06 2020-04 Issued Notice of Compliance Buprenorphine Other nervous system drugs 215660 2018-05 2018-11 Issued Notice of Compliance Buprenorphine hydrochloride Other nervous system drugs 196428 2016-08 2017-06 Issued Notice of Compliance Buprenorphine hydrochloride Other nervous system drugs 204746 2017-06 2018-04 Issued Notice of Compliance Bupropion hydrochloride, naltrexone hydrochloride Antiobesity preparations, excluding diet products 202774 2017-04 2018-02 Issued Notice of Compliance Burosumab Drugs for treatment of bone diseases 216239 2018-06 2018-12 Issued Notice of Compliance C1 esterase inhibitor (human) Other hematological agents 198308 2016-11 2017-09 Issued Notice of Compliance Cabotegravir, rilpivirine Antivirals for systemic use 227315 2019-05 2020-03 Issued Notice of Compliance Cabozantinib Antineoplastic agents 206230 2017-07 2018-09 Issued Notice of Compliance Caffeine citrate Psychoanaleptics 225810 2019-05 2020-03 Issued Notice of Compliance Calcifediol Vitamins 205392 2017-09 2018-07 Issued Notice of Compliance Canakinumab Immunosuppressants 213303 2018-06 2018-12 Cancelled by sponsor Caplacizumab Antithrombotic agents 230001 2019-08 2020-02 Issued Notice of Compliance Carfilzomib Antineoplastic agents 184479 2015-07 2016-01 Issued Notice of Compliance Cedazuridine, decitabine Antineoplastic agents 234610 2020-01 2020-07 Issued Notice of Compliance Cefixime Antibacterials for systemic use 189720 2016-05 2017-10 Issued Notice of Compliance Cemiplimab Antineoplastic agents 218718 2018-08 2019-04 Issued Notice of Compliance under the NOC/c Guidance Cenegermin Ophthalmologicals 218145 2018-08 2019-02 Issued Notice of Compliance Cerliponase alfa Other alimentary tract and metabolism products 216539 2018-06 2018-12 Issued Notice of Compliance Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride Blood substitutes and perfusion solutions 223801 2019-06 2020-04 Issued Notice of Compliance Cidofovir Antivirals for systemic use 200865 2017-04 2018-03 Issued Notice of Compliance Cinnarizine, dimenhydrinate Other nervous system drugs 195151 2016-09 2018-11 Issued Notice of Non-compliance- Withdrawal Cladribine Immunosuppressants 200943 2017-02 2017-11 Issued Notice of Compliance Clozapine Psycholeptics 193638 2016-05 2016-11 Issued Notice of Compliance Coagulation factor IX (recombinant), pegylated Antihemorrhagics 201114 2017-02 2017-11 Issued Notice of Compliance Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 199705 2017-05 2018-03 Issued Notice of Compliance Cobimetinib fumarate Antineoplastic agents 182788 2015-04 2016-02 Issued Notice of Compliance Crisaborole Other dermatological preparations 206906 2017-08 2018-06 Issued Notice of Compliance Cyclosporine Ophthalmologicals 194580 2016-08 2018-04 Issued Notice of Non-compliance- Withdrawal Cyclosporine Ophthalmologicals 215813 2018-07 2018-12 Issued Notice of Compliance Cysteamine hydrochloride Ophthalmologicals 211635 2018-02 2019-02 Issued Notice of Compliance Daclizumab Immunosuppressants 190458 2016-02 2016-12 Issued Notice of Compliance Dacomitinib Antineoplastic agents 214572 2018-05 2019-02 Issued Notice of Compliance Dalbavancin Antibacterials for systemic use 212390 2018-03 2018-09 Issued Notice of Compliance Daratumumab Antineoplastic agents 187648 2015-11 2016-06 Issued Notice of Compliance under the NOC/c Guidance Darolutamide Endocrine therapy 226146 2019-04 2020-02 Issued Notice of Compliance Darvadstrocel Unassigned 217347 2018-08 2019-06 Cancelled by sponsor Decitabine Antineoplastic agents 207372 2018-03 2019-01 Issued Notice of Compliance Decitabine Antineoplastic agents 217663 2018-09 2019-07 Issued Notice of Compliance Defibrotide Antithrombotic agents 200808 2017-01 2017-07 Issued Notice of Compliance Dermatophagoides farinae, dermatophagoides pteronyssinus Allergens 208152 2017-09 2020-07 Cancelled by sponsor Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 195186 2016-07 2017-05 Issued Notice of Compliance Desvenlafaxine Psychoanaleptics 199626 2017-02 2017-08 Issued Notice of Compliance Dexamethasone sodium phosphate, netilmicin sulfate Ophthalmologicals 212391 2018-02 2019-10 Issued Notice of Compliance Dinutuximab Antineoplastic agents 212066 2018-02 2018-11 Issued Notice of Compliance Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, 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Antithrombotic agents 233987 2020-01 2020-11 Issued Notice of Compliance Enoxaparin sodium Antithrombotic agents 231767 2019-11 2020-12 Issued Notice of Compliance Entrectinib Antineoplastic agents 227517 2019-06 2020-02 Issued Notice of Compliance under the NOC/c Guidance Entrectinib Antineoplastic agents 228159 2019-07 2020-05 Issued Notice of Compliance Erdafitinib Antineoplastic agents 224529 2019-03 2019-10 Issued Notice of Compliance under the NOC/c Guidance Erenumab Analgesics 208607 2017-10 2018-08 Issued Notice of Compliance Ertugliflozin pidolate Drugs used in diabetes 204724 2017-07 2018-05 Issued Notice of Compliance Ertugliflozin pidolate, metformin hydrochloride Drugs used in diabetes 201005 2017-08 2018-05 Issued Notice of Compliance Ertugliflozin pidolate, sitagliptin phosphate monohydrate Drugs used in diabetes 201006 2017-07 2018-05 Issued Notice of Compliance Esketamine hydrochloride Psychoanaleptics 222855 2019-01 2020-05 Issued Notice of Compliance Estradiol hemihydrate, progesterone Sex hormones and modulators of the genital system 224010 2019-11 2020-09 Issued Notice of Compliance Estriol, lactobacillus acidophilus Sex hormones and modulators of the genital system 203472 2017-06 2019-01 Issued a Notice of Deficiency-Withdrawal Etanercept Immunosuppressants 193864 2016-06 2017-04 Issued Notice of Compliance Etomidate Anesthetics 231245 2019-12 2020-07 Issued Notice of Compliance Etonogestrel Sex hormones and modulators of the genital system 226314 2019-05 2020-05 Issued Notice of Compliance Fedratinib dihydrochloride monohydrate Antineoplastic agents 229866 2019-10 2020-07 Issued Notice of Compliance Fibrinogen (human) Antihemorrhagics 195870 2016-08 2017-06 Issued Notice of Compliance Filgrastim (r-metHuG-CSF) Immunostimulants 212016 2018-02 2019-08 Cancelled by sponsor Filgrastim (r-metHuG-CSF) Immunostimulants 214080 2018-04 2020-04 Issued Notice of Compliance Flibanserin Other gynecologicals 189352 2016-04 2018-02 Issued Notice of Compliance Florbetaben (18F) Diagnostic radiopharmaceuticals 193105 2016-04 2017-02 Issued Notice of Compliance Fluocinolone acetonide Ophthalmologicals 201510 2017-02 2018-11 Issued Notice of Compliance Fluorouracil Antineoplastic agents 211768 2018-04 2019-02 Issued Notice of Compliance Fluoxetine hydrochloride Psychoanaleptics 198520 2016-12 2017-06 Issued Notice of Compliance Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 204880 2017-06 2018-04 Issued Notice of Compliance Fluticasone propionate Drugs for obstructive airway diseases 197873 2016-10 2017-08 Issued Notice of Compliance Fluticasone proprionate, salmeterol xinafoate Drugs for obstructive airway diseases 197974 2016-11 2018-04 Issued Notice of Compliance Follitropin delta Sex hormones and modulators of the genital system 188743 2016-01 2018-03 Issued Notice of Compliance Formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 201306 2017-02 2018-03 Issued Notice of Compliance Foscarnet sodium Antivirals for systemic use 233046 2019-12 2020-10 Issued Notice of Compliance Fosfomycin sodium Antibacterials for systemic use 219662 2018-11 2019-05 Issued Notice of Compliance Fostamatinib disodium Antihemorrhagics 232078 2020-01 2020-11 Issued Notice of Compliance Fremanezumab Analgesics 226828 2019-06 2020-04 Issued Notice of Compliance Gadoteric acid Contrast media 186333 2015-12 2016-11 Issued Notice of Compliance Galcanezumab Analgesics 219521 2018-10 2019-07 Issued Notice of Compliance Gallium (68Ga) chloride Diagnostic radiopharmaceuticals 221824 2019-04 2019-11 Issued Notice of Compliance Gallium (68Ga) chloride, germanium (68Ge) chloride Diagnostic radiopharmaceuticals 227804 2019-10 2020-08 Issued Notice of Compliance Gemtuzumab ozogamicin Antineoplastic agents 223091 2019-02 2019-11 Issued Notice of Compliance Gilteritinib fumarate Antineoplastic agents 227918 2019-06 2019-12 Issued Notice of Compliance Givosiran Bile and liver therapy 237194 2020-04 2020-10 Issued Notice of Compliance Glasdegib Antineoplastic agents 225793 2019-07 2020-04 Issued Notice of Compliance Glecaprevir, pibrentasvir Antivirals for systemic use 202233 2017-02 2017-08 Issued Notice of Compliance Glucagon Pancreatic hormones 220839 2018-11 2019-09 Issued Notice of Compliance Glycine, histidine, L-alanine, L-arginine, L-isoleucine, L-leucine, L-lysine acetate, L-methionine, L-phenylalanine, L-proline, L-threonine, L-tryptophan, L-tyrosine, L-valine, serine, taurine Blood substitutes and perfusion solutions 231585 2020-03 2020-12 Issued Notice of Compliance Glycopyrrolate Drugs for functional gastrointestinal disorders 197038 2017-01 2017-10 Issued Notice of Compliance Glycopyrronium bromide, indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 228353 2019-09 2020-07 Issued Notice of Compliance Guselkumab Immunosuppressants 200590 2017-01 2017-11 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B treatments 200726 2017-05 2019-03 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) treatments 203436 2017-04 2018-02 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) treatments 222669 2019-01 2019-11 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) treatments 234113 2020-01 2020-11 Cancelled by sponsor Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations 212718 2018-05 2020-06 Issued Notice of Compliance Hemin Other alimentary tract and metabolism 212276 2018-01 2018-07 Issued Notice of Compliance Human heterologous liver cells Other alimentary tract and metabolism products 205160 2017-06 2018-07 Cancelled by sponsor Hydrochlorothiazide, zofenopril calcium Agents acting on the renin-angiotensin system 212396 2018-06 2019-06 Cancelled by sponsor Hydrogen peroxide Other dermatological preparations 216854 2018-12 2019-08 Cancelled by sponsor Icosapent ethyl Lipid modifying agents 227235 2019-07 2019-12 Issued Notice of Compliance Idarucizumab All other therapeutic products 182503 2015-05 2016-04 Issued Notice of Compliance under the NOC/c Guidance Immunoglobulin (human) Immune sera and immunoglobulins 194291 2016-10 2017-08 Issued Notice of Compliance Immunoglobulin (human) Immune sera and immunoglobulins 226576 2019-06 2019-12 Issued Notice of Compliance Immunoglobulin G (human) Immune sera and immunoglobulins 202924 2017-04 2018-02 Issued Notice of Compliance Indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 227987 2019-07 2020-05 Issued Notice of Compliance Infliximab Immunosuppressants 226189 2019-05 2020-03 Issued Notice of Compliance Inotersen sodium Other nervous system drugs 214274 2018-04 2018-10 Issued Notice of Compliance Inotuzumab ozogamicin Antineoplastic agents 204077 2017-05 2018-03 Issued Notice of Compliance Insulin aspart Drugs used in diabetes 226573 2019-12 2020-10 Issued Notice of Compliance Insulin degludec Drugs used in diabetes 198124 2016-10 2017-08 Issued Notice of Compliance Insulin degludec, liraglutide Drugs used in diabetes 194513 2017-06 2018-04 Issued Notice of Compliance Insulin glargine Drugs used in diabetes 202772 2017-04 2019-02 Cancelled by sponsor Insulin glargine, lixisenatide Drugs used in diabetes 207006 2017-09 2018-07 Issued Notice of Compliance Insulin injection human biosynthetic Drugs used in diabetes 189076 2016-09 2017-07 Issued Notice of Compliance Insulin lispro Drugs used in diabetes 200792 2017-01 2017-11 Issued Notice of Compliance Iodine Contrast media 196107 2016-09 2017-07 Issued Notice of Compliance Ioflupane (123I) Diagnostic radiopharmaceuticals 201481 2017-02 2017-12 Issued Notice of Compliance Iron dextran Antianemic preparations 189897 2016-05 2017-06 Cancelled by sponsor Iron isomaltoside 1000 Antianemic preparations 193890 2016-07 2018-06 Issued Notice of Compliance Isatuximab Antineoplastic agents 229245 2019-07 2020-04 Issued Notice of Compliance Isavuconazonium sulfate Antimycotics for systemic use 208919 2018-02 2018-12 Issued Notice of Compliance Ivacaftor, tezacaftor Other respiratory system products 211292 2017-12 2018-06 Issued Notice of Compliance Ivermectin Anthelmintics 211000 2017-12 2018-09 Issued Notice of Compliance Ixazomib citrate Antineoplastic agents 190498 2016-02 2016-08 Issued Notice of Compliance Ixekizumab Immunosuppressants 184993 2015-07 2016-05 Issued Notice of Compliance Lanadelumab Other hematological agents 213920 2018-03 2018-09 Issued Notice of Compliance Larotrectinib Antineoplastic agents 219998 2018-11 2019-07 Issued Notice of Compliance under the NOC/c Guidance Latanoprostene bunod Ophthalmologicals 211732 2018-03 2018-12 Issued Notice of Compliance Lefamulin acetate Antibacterials for systemic use 233292 2020-01 2020-07 Issued Notice of Compliance Lemborexant Psycholeptics 231286 2020-01 2020-11 Issued Notice of Compliance Letermovir Antivirals for systemic use 204165 2017-05 2017-11 Issued Notice of Compliance Levetiracetam Antiepileptics 213656 2018-09 2019-07 Issued Notice of Compliance Levothyroxine sodium Thyroid therapy 232047 2020-01 2020-11 Issued Notice of Compliance Lifitegrast Ophthalmologicals 199810 2016-12 2017-12 Issued Notice of Compliance Lixisenatide Drugs used in diabetes 193862 2016-06 2017-05 Issued Notice of Compliance Lonoctocog alfa Antihemorrhagics 190891 2016-02 2016-12 Issued Notice of Compliance Lorcaserin hydrochloride Antiobesity preparations, excluding diet products 198689 2016-11 2018-02 Cancelled by sponsor Lorlatinib Antineoplastic agents 215733 2018-06 2019-02 Issued Notice of Compliance under the NOC/c Guidance Luspatercept Antianemic preparations 236441 2020-03 2020-09 Issued Notice of Compliance Lutetium (177Lu) oxodotretotide Therapeutic radiopharmaceuticals 217184 2018-07 2019-01 Issued Notice of Compliance Mannitol Diagnostic agents 217446 2018-08 2019-06 Issued Notice of Compliance Mecasermin Pituitary, hypothalamic hormones and analogues 235023 2020-02 2020-12 Issued Notice of Compliance Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate treatments 233632 2020-01 2020-10 Issued Notice of Compliance Mercaptamine bitartrate Other alimentary tract and metabolism products 191347 2016-03 2017-06 Issued Notice of Compliance Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 204605 2017-05 2018-03 Issued Notice of Compliance Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 198475 2017-02 2020-08 Cancelled by sponsor Methoxyflurane Analgesics 204879 2017-06 2018-04 Issued Notice of Compliance Midostaurin Antineoplastic agents 201101 2017-01 2017-07 Issued Notice of Compliance Migalastat hydrochloride Other alimentary tract and metabolism products 196956 2016-11 2017-09 Issued Notice of Compliance Mometasone furoate Corticosteroids, dermatological preparations 199704 2017-09 2019-10 Cancelled by sponsor Naloxone hydrochloride All other therapeutic products 193199 2016-04 2016-10 Issued Notice of Compliance Naloxone hydrochloride dihydrate All other therapeutic products 211970 2018-01 2019-06 Cancelled by sponsor Naproxen sodium, sumatriptan succinate Analgesics 225848 2019-05 2020-02 Issued Notice of Compliance Necitumumab Antineoplastic agents 193689 2016-05 2017-03 Issued Notice of Compliance Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B treatments 195550 2016-07 2017-10 Issued Notice of Compliance Neratinib maleate Antineoplastic agents 218224 2018-09 2019-07 Issued Notice of Compliance Netupitant, palonosetron hydrochloride Antiemetics and antinauseants 196495 2016-12 2017-09 Issued Notice of Compliance Nicardipine hydrochloride Calcium channel blockers 216257 2018-07 2020-04 Issued Notice of Non-compliance - Withdrawal Niraparib Antineoplastic agents 216792 2018-09 2019-06 Issued Notice of Compliance Nitisinone Other alimentary tract and metabolism products 190564 2016-03 2016-09 Issued Notice of Compliance Nitisinone Other alimentary tract and metabolism products 193226 2016-07 2016-12 Issued Notice of Compliance Nitisinone Other alimentary tract and metabolism products 193770 2016-05 2016-11 Issued Notice of Compliance Nusinersen Other drugs for disorders of the musculo-skeletal systemOther 200070 2016-12 2017-06 Issued Notice of Compliance Obeticholic acid Bile and liver therapy 198418 2016-10 2017-05 Issued Notice of Compliance under the NOC/c Guidance Obiltoxaximab Immune sera and immunoglobulins 230825 2019-10 2020-07 Issued Notice of Compliance Ocrelizumab Immunosuppressants 198094 2016-10 2017-08 Issued Notice of Compliance Ocrelizumab Immunosuppressants 197969 2016-10 2018-02 Issued Notice of Compliance under the NOC/c Guidance Olaparib Antineoplastic agents 182823 2015-06 2016-04 Issued Notice of Compliance under the NOC/c Guidance Olaratumab Antineoplastic agents 203478 2017-04 2017-11 Issued Notice of Compliance under the NOC/c Guidance Onasemnogene abeparvovec Other drugs for disorders of the musculo-skeletal system 239719 2020-06 2020-12 Issued Notice of Compliance Osimertinib Antineoplastic agents 188171 2015-11 2016-07 Issued Notice of Compliance under the NOC/c Guidance Oxycodone Analgesics 198865 2016-11 2018-07 Cancelled by sponsor Ozanimod hydrochloride Immunosuppressants 232761 2019-12 2020-10 Issued Notice of Compliance Ozenoxacin Antibiotics and chemotherapy for dermatological use 192925 2016-07 2017-05 Issued Notice of Compliance Panobinostat Antineoplastic agents 187504 2015-11 2016-06 Cancelled by sponsor Patiromer sorbitex calcium All other therapeutic products 210368 2017-12 2018-10 Issued Notice of Compliance Patisiran Other nervous system drugs 221896 2018-12 2019-06 Issued Notice of Compliance Pegaspargase Antineoplastic agents 189795 2016-05 2017-02 Issued Notice of Compliance Pegfilgrastim Immunostimulants 204841 2017-06 2018-04 Issued Notice of Compliance Pegfilgrastim Immunostimulants 200807 2017-01 2018-12 Issued Notice of Compliance Pegfilgrastim Immunostimulants 220445 2019-05 2020-04 Issued Notice of Compliance Pegfilgrastim Immunostimulants 233373 2020-01 2020-10 Issued Notice of Compliance Peramivir Antivirals for systemic use 191280 2016-03 2017-01 Issued Notice of Compliance Perindopril arginine Agents acting on the renin-angiotensin system 201189 2017-08 2018-03 Issued Notice of Compliance Plecanatide Drugs for constipation 215288 2018-12 2019-10 Issued Notice of Compliance Polatuzumab vedotin Antineoplastic agents 232303 2019-11 2020-07 Issued Notice of Compliance under the NOC/c Guidance PrabotulinumtoxinA Muscle relaxants 208364 2017-10 2018-08 Issued Notice of Compliance Pralatrexate Antineoplastic agents 207545 2017-11 2018-10 Issued Notice of Compliance under the NOC/c Guidance Prasterone Anabolic agents for systemic use 198822 2016-12 2019-11 Issued Notice of Compliance Progesterone Sex hormones and modulators of the genital system 211548 2018-02 2018-08 Issued Notice of Compliance Propiverine hydrochloride Urologicals 188323 2016-03 2017-01 Issued Notice of Compliance Rabies immunoglobulin, human Immune sera and immunoglobulins 211541 2018-01 2018-11 Issued Notice of Compliance Ranolazine Cardiac therapy 239943 2020-07 2020-12 Issued Notice of Compliance Ravulizumab Immunosuppressants 217955 2018-11 2019-08 Issued Notice of Compliance Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) Antihemorrhagics 180793 2015-04 2016-01 Issued Notice of Compliance Remdesivir Antivirals for systemic use 240551 2020-07 2020-07 Issued Notice of Compliance under the NOC/c Guidance Reslizumab Immunosuppressants 185873 2015-09 2016-07 Issued Notice of Compliance Ribociclib Antineoplastic agents 203884 2017-05 2018-03 Issued Notice of Compliance Ripretinib Antineoplastic agents 234688 2020-03 2020-06 Issued Notice of Compliance Risankizumab Immunosuppressants 215753 2018-06 2019-04 Issued Notice of Compliance Risperidone Psycholeptics 233331 2020-01 2020-11 Issued Notice of Compliance Rituximab Antineoplastic agents 207702 2017-09 2019-03 Cancelled by sponsor Rituximab Antineoplastic agents 208107 2017-09 2019-03 Cancelled by sponsor Rituximab Antineoplastic agents 208204 2017-09 2019-04 Issued Notice of Compliance Rituximab Antineoplastic agents 224672 2019-03 2019-04 Cancelled by sponsor Rituximab Antineoplastic agents 214058 2018-04 2020-04 Issued Notice of Compliance Rituximab Antineoplastic agents 224164 2019-03 2020-05 Issued Notice of Compliance Romosozumab Drugs for treatment of bone diseases 197713 2016-10 2019-06 Issued Notice of Compliance Rupatadine fumarate Antihistamines for systemic use 186488 2015-09 2016-07 Issued Notice of Compliance Safinamide Anti-parkinson drugs 207115 2018-03 2019-01 Issued Notice of Compliance Salbutamol sulfate Drugs for obstructive airway diseases 189577 2016-11 2017-11 Issued Notice of Compliance Sarilumab Immunosuppressants 191745 2016-03 2017-01 Issued Notice of Compliance Satralizumab Immunosuppressants 233642 2019-12 2020-06 Issued Notice of Compliance Sebelipase alfa Other alimentary tract and metabolism products 204085 2017-04 2017-12 Issued Notice of Compliance under the NOC/c Guidance Semaglutide Drugs used in diabetes 202059 2017-03 2018-01 Issued Notice of Compliance Semaglutide Drugs used in diabetes 226906 2019-06 2020-03 Issued Notice of Compliance Siponimod Immunosuppressants 223225 2019-02 2020-02 Issued Notice of Compliance Sirukumab Immunosuppressants 205568 2017-06 2017-10 Cancelled by sponsor Sodium chloride, sodium citrate Blood substitutes and perfusion solutions 225953 2019-05 2020-03 Issued Notice of Compliance Sodium pertechnetate Tc-99m Diagnostic radiopharmaceuticals 231915 2020-01 2020-11 Issued Notice of Compliance Sodium zirconium cyclosilicate All other therapeutic products 218799 2018-09 2019-07 Issued Notice of Compliance Sofosbuvir, velpatasvir Antivirals for systemic use 190521 2016-01 2016-07 Issued Notice of Compliance Sofosbuvir, velpatasvir, voxilaprevir Antivirals for systemic use 202324 2017-02 2017-08 Issued Notice of Compliance Sonidegib Antineoplastic agents 229407 2019-08 2020-06 Issued Notice of Compliance Sotagliflozin Drugs used in diabetes 217853 2018-08 2019-06 Cancelled by sponsor Sucroferric oxyhydroxide All other therapeutic products 201492 2017-02 2018-01 Issued Notice of Compliance Sugammadex All other therapeutic products 180385 2015-04 2016-02 Issued Notice of Compliance Suvorexant Psycholeptics 196367 2016-08 2018-11 Issued Notice of Compliance Tacrolimus Immunosuppressants 209210 2018-04 2019-02 Issued Notice of Compliance Tafamidis meglumine Other nervous system drugs 228368 2019-07 2020-01 Issued Notice of Compliance Talazoparib Antineoplastic agents 220584 2018-11 2019-09 Issued Notice of Compliance Telotristat etiprate Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 208730 2017-12 2018-10 Issued Notice of Compliance Tenapanor Drugs for constipation 224850 2019-06 2020-04 Issued Notice of Compliance Tenofovir alafenamide hemifumarate Antivirals for systemic use 193066 2016-07 2017-05 Issued Notice of Compliance Teriparatide Calcium homeostasis 215409 2018-06 2020-01 Issued Notice of Compliance Tibolone Sex hormones and modulators of the genital system 206099 2017-10 2019-05 Issued Notice of Compliance Tipiracil hydrochloride, trifluridine Antineoplastic agents 205852 2017-07 2018-01 Issued Notice of Compliance Tisagenlecleucel-T Antineoplastic agents 213547 2018-03 2018-09 Issued Notice of Compliance Tisagenlecleucel-T Antineoplastic agents 213698 2018-03 2018-09 Issued Notice of Compliance Trastuzumab Antineoplastic agents 204579 2017-06 2019-05 Issued Notice of Compliance Trastuzumab Antineoplastic agents 212140 2018-02 2019-08 Issued Notice of Compliance Trastuzumab Antineoplastic agents 210238 2017-11 2019-09 Issued Notice of Compliance Trastuzumab Antineoplastic agents 208836 2017-10 2020-02 Issued Notice of Compliance Triamcinolone hexacetonide Corticosteroids for systemic use 201546 2017-02 2017-12 Issued Notice of Compliance Trientine hydrochloride Other alimentary tract and metabolism products 228708 2019-11 2020-09 Issued Notice of Compliance Trifarotene Anti-acne preparations 221945 2019-01 2019-11 Issued Notice of Compliance Tucatinib Antineoplastic agents 235295 2020-02 2020-06 Issued Notice of Compliance Upadacitinib Immunosuppressants 223734 2019-03 2019-12 Issued Notice of Compliance Varicella-zoster ventolin glycoprotein E (GE) treatments 200244 2016-12 2017-10 Issued Notice of Compliance Venetoclax Antineoplastic agents 190761 2016-02 2016-09 Issued Notice of Compliance under the NOC/c Guidance Vernakalant hydrochloride Cardiac therapy 190817 2016-05 2017-03 Issued Notice of Compliance Volanesorsen Lipid modifying agents 209280 2017-11 2018-11 Issued Notice of Non-compliance - Withdrawal Vonicog alfa Antihemorrhagics 213188 2018-03 2019-01 Issued Notice of Compliance Voretigene neparvovec Ophthalmologicals 233097 2019-12 2020-10 Issued Notice of Compliance Zofenopril calcium Agents acting on the renin-angiotensin system 212392 2018-06 2019-06 Cancelled by sponsor.

5-Aminolevulinic acid Antineoplastic agents 234673 2020-03 2020-09 Issued Notice of Compliance Abemaciclib Antineoplastic agents 215268 2018-06 2019-04 Issued Notice of Compliance Acalabrutinib Antineoplastic agents 214504 2018-04 2019-08 Issued Notice of Compliance Acetaminophen Analgesics 209478 2018-02 2018-11 Issued Notice of Compliance Adalimumab Immunosuppressants 203250 2017-04 2018-05 Issued Notice of Compliance Adalimumab Immunosuppressants 203292 2017-04 2018-05 Issued Notice of Compliance Adalimumab Immunosuppressants 230637 2019-10 2020-10 Issued Notice of Compliance Adalimumab Immunosuppressants 217314 2018-11 2020-11 Issued Notice of Compliance Adalimumab Immunosuppressants 229124 2019-09 2020-11 Issued Notice of Compliance Alectinib Antineoplastic agents 189442 2016-02 2016-09 Issued Notice of Compliance under the NOC/c Guidance Alirocumab Lipid modifying agents 183116 2015-06 2016-04 Issued Notice of Compliance Alpelisib Antineoplastic agents 226941 2019-05 2020-03 Issued Notice of Compliance Alvimopan Drugs for constipation 189825 2016-03 2017-03 Cancelled by sponsor Amifampridine Other nervous system drugs 234655 2020-02 2020-08 Issued Notice of Compliance Amifampridine phosphate Other nervous system drugs 232685 2020-02 2020-07 Issued Notice of Compliance Amlodipine besylate Calcium channel blockers 211854 2018-07 2019-01 Issued Notice of Compliance Amoxicillin sodium, clavulanic acid Antibacterials for systemic use 221964 2019-04 2020-01 Issued Notice of Compliance Anthrax antigen filtrate treatments 212387 2018-02 2018-12 Issued Notice of Compliance Anthrax immunoglobulin (human) Immune sera and immunoglobulins 200446 2017-01 2017-11 Issued Notice of Compliance Antihemophilic factor (human), Von Willebrand factor (human) Antihemorrhagics 194071 2017-06 2018-05 Issued Notice of Compliance Antihemophilic factor (recombinant), pegylated Antihemorrhagics 189709 2016-01 2016-11 Issued Notice of Compliance Antihemophilic factor (recombinant, B-domain deleted, pegylated) Antihemorrhagics 210935 2017-12 2018-10 Issued Notice of Compliance Antihemophilic factor VIII (Recombinant, B-domain truncated), pegylated Antihemorrhagics 218531 2018-09 2019-07 Issued Notice of Compliance Apalutamide Endocrine therapy 211942 2018-01 2018-07 Issued Notice of Compliance Apomorphine hydrochloride Anti-parkinson drugs 217320 2018-08 2020-06 Issued Notice of Compliance Ataluren Other drugs for disorders of the musculo-skeletal system 186992 2015-09 2016-03 Cancelled by sponsor Ataluren Other drugs for disorders of the musculo-skeletal system 217349 2018-09 2019-10 Cancelled by sponsor Atezolizumab Antineoplastic agents 196843 2016-08 2017-04 Issued Notice of Compliance under the NOC/c Guidance Avelumab Antineoplastic agents 204052 2017-04 2017-12 Issued Notice of Compliance under the NOC/c Guidance Avelumab Antineoplastic agents 208742 2017-09 2018-05 Issued Notice of Compliance under the NOC/c Guidance Axicabtagene ciloleucel Antineoplastic agents 218389 2018-08 2019-02 Issued Notice of Compliance Bacillus Calmette-Guerin BCG - Strain Russian BCG-I Immunostimulants 221579 2018-12 2020-12 Issued Notice of Compliance under the NOC/c Guidance Baloxavir marboxil Antivirals for systemic use 227361 2019-05 2020-02 Issued Notice of Compliance Baricitinib Antiinflammatory and antirheumatic products 193687 2016-05 2018-08 Issued Notice of Compliance Belinostat Antineoplastic agents 208886 2017-12 2019-11 Cancelled by sponsor Benralizumab Immunosuppressants 204008 2017-04 2018-02 Issued Notice of Compliance Bepotastine besilate Ophthalmologicals 179294 2015-10 2016-07 Issued Notice of Compliance Betamethasone valerate, fusidic acid Corticosteroids, dermatological preparations 203765 2017-06 2018-04 Issued Notice of Compliance Betula verrucosa extract Nasal preparations 227270 2019-06 2020-04 Issued Notice of Compliance Bevacizumab Antineoplastic agents 201427 2017-02 2018-04 Issued Notice of Compliance Bevacizumab Antineoplastic agents 218183 2018-08 2019-06 Issued Notice of Compliance Bictegravir sodium, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 203718 2017-09 2018-07 Issued Notice of Compliance Bilastine Antihistamines for systemic use 184231 2015-06 2016-04 Issued Notice of Compliance Bisoprolol fumarate Beta blocking agents 203050 2017-07 2019-11 Issued Notice of Compliance Bisoprolol fumarate Beta blocking agents 231842 2020-05 2020-09 Cancelled by sponsor Bivalirudin Antithrombotic agents 232423 2019-11 2020-09 Issued Notice of Compliance Blinatumomab Antineoplastic agents 181723 2015-04 2015-12 Issued Notice of Compliance under the NOC/c Guidance Botulinum antitoxin, serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins 190645 2016-02 2016-12 Issued Notice of Compliance Brexpiprazole Psycholeptics 192684 2016-04 2017-02 Issued Notice of Compliance Brigatinib Antineoplastic agents 210369 2017-11 2018-07 Issued Notice of Compliance under the NOC/c Guidance Brivaracetam Antiepileptics 183355 2015-05 2016-03 Issued Notice of Compliance Brodalumab Immunosuppressants 195317 2016-07 2018-03 Issued Notice of Compliance Brolucizumab Ophthalmologicals 226224 2019-05 2020-03 Issued Notice of Compliance Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 227232 2019-05 2019-11 Issued Notice of Compliance Budesonide Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 220876 2019-06 2020-04 Issued Notice of Compliance Buprenorphine Other nervous system drugs 215660 2018-05 2018-11 Issued Notice of Compliance Buprenorphine hydrochloride Other nervous system drugs 196428 2016-08 2017-06 Issued Notice of Compliance Buprenorphine hydrochloride Other nervous system drugs 204746 2017-06 2018-04 Issued Notice of Compliance Bupropion hydrochloride, naltrexone hydrochloride Antiobesity preparations, excluding diet products 202774 2017-04 2018-02 Issued Notice of Compliance Burosumab Drugs for treatment of bone diseases 216239 2018-06 2018-12 Issued Notice of Compliance C1 esterase inhibitor (human) Other hematological agents 198308 2016-11 2017-09 Issued Notice of Compliance Cabotegravir, rilpivirine Antivirals for systemic use 227315 2019-05 2020-03 Issued Notice of Compliance Cabozantinib Antineoplastic agents 206230 2017-07 2018-09 Issued Notice of Compliance Caffeine citrate Psychoanaleptics 225810 2019-05 2020-03 Issued Notice of Compliance Calcifediol Vitamins 205392 2017-09 2018-07 Issued Notice of Compliance Canakinumab Immunosuppressants 213303 2018-06 2018-12 Cancelled by sponsor Caplacizumab Antithrombotic agents 230001 2019-08 2020-02 Issued Notice of Compliance Carfilzomib Antineoplastic agents 184479 2015-07 2016-01 Issued Notice of Compliance Cedazuridine, decitabine Antineoplastic agents 234610 2020-01 2020-07 Issued Notice of Compliance Cefixime Antibacterials for systemic use 189720 2016-05 2017-10 Issued Notice of Compliance Cemiplimab Antineoplastic agents 218718 2018-08 2019-04 Issued Notice of Compliance under the NOC/c Guidance Cenegermin Ophthalmologicals 218145 2018-08 2019-02 Issued Notice of Compliance Cerliponase alfa Other alimentary tract and metabolism products 216539 2018-06 2018-12 Issued Notice of Compliance Chromic chloride, cupric chloride, ferric chloride, manganese chloride, potassium iodide, sodium fluoride, sodium molybdate, sodium selenite, zinc chloride Blood substitutes and perfusion solutions 223801 2019-06 2020-04 Issued Notice of Compliance Cidofovir Antivirals for systemic use 200865 2017-04 2018-03 Issued Notice of Compliance Cinnarizine, dimenhydrinate Other nervous system drugs 195151 2016-09 2018-11 Issued Notice of Non-compliance- Withdrawal Cladribine Immunosuppressants 200943 2017-02 2017-11 Issued Notice of Compliance Clozapine Psycholeptics 193638 2016-05 2016-11 Issued Notice of Compliance Coagulation factor IX (recombinant), pegylated Antihemorrhagics 201114 2017-02 2017-11 Issued Notice of Compliance Cobicistat, darunavir ethanolate, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use 199705 2017-05 2018-03 Issued Notice of Compliance Cobimetinib fumarate Antineoplastic agents 182788 2015-04 2016-02 Issued Notice of Compliance Crisaborole Other dermatological preparations 206906 2017-08 2018-06 Issued Notice of Compliance Cyclosporine Ophthalmologicals 194580 2016-08 2018-04 Issued Notice of Non-compliance- Withdrawal Cyclosporine Ophthalmologicals 215813 2018-07 2018-12 Issued Notice of Compliance Cysteamine hydrochloride Ophthalmologicals 211635 2018-02 2019-02 Issued Notice of Compliance Daclizumab Immunosuppressants 190458 2016-02 2016-12 Issued Notice of Compliance Dacomitinib Antineoplastic agents 214572 2018-05 2019-02 Issued Notice of Compliance Dalbavancin Antibacterials for systemic use 212390 2018-03 2018-09 Issued Notice of Compliance Daratumumab Antineoplastic agents 187648 2015-11 2016-06 Issued Notice of Compliance under the NOC/c Guidance Darolutamide Endocrine therapy 226146 2019-04 2020-02 Issued Notice of Compliance Darvadstrocel Unassigned 217347 2018-08 2019-06 Cancelled by sponsor Decitabine Antineoplastic agents 207372 2018-03 2019-01 Issued Notice of Compliance Decitabine Antineoplastic agents 217663 2018-09 2019-07 Issued Notice of Compliance Defibrotide Antithrombotic agents 200808 2017-01 2017-07 Issued Notice of Compliance Dermatophagoides farinae, dermatophagoides pteronyssinus Allergens 208152 2017-09 2020-07 Cancelled by sponsor Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens 195186 2016-07 2017-05 Issued Notice of Compliance Desvenlafaxine Psychoanaleptics 199626 2017-02 2017-08 Issued Notice of Compliance Dexamethasone sodium phosphate, netilmicin sulfate Ophthalmologicals 212391 2018-02 2019-10 Issued Notice of Compliance Dinutuximab Antineoplastic agents 212066 2018-02 2018-11 Issued Notice of Compliance Disodium phosphate, magnesium chloride, potassium chloride, sodium acetate, 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Other nervous system drugs 214391 2018-04 2018-10 Issued Notice of Compliance Edoxaban Antithrombotic agents 187363 2015-12 2016-11 Issued Notice of Compliance Elagolix Sex hormones and modulators of the genital system 209513 2017-12 2018-10 Issued Notice of Compliance Elbasvir, grazoprevir Antivirals for systemic use 185866 2015-07 2016-01 Issued Notice of Compliance Eliglustat tartrate Other alimentary tract and metabolism products 183050 2015-05 2017-04 Issued Notice of Compliance Elotuzumab Antineoplastic agents 188144 2015-12 2016-06 Issued Notice of Compliance Eluxadoline Drugs for functional gastrointestinal disorders 190162 2016-04 2017-01 Issued Notice of Compliance Emicizumab Antihemorrhagics 212635 2018-02 2018-08 Issued Notice of Compliance Enasidenib mesylate Antineoplastic agents 217033 2018-07 2019-02 Issued Notice of Compliance under the NOC/c Guidance Enoxaparin sodium Antithrombotic agents 233058 2019-12 2020-10 Issued Notice of Compliance Enoxaparin sodium Antithrombotic agents 233987 2020-01 2020-11 Issued Notice of Compliance Enoxaparin sodium Antithrombotic agents 231767 2019-11 2020-12 Issued Notice of Compliance Entrectinib Antineoplastic agents 227517 2019-06 2020-02 Issued Notice of Compliance under the NOC/c Guidance Entrectinib Antineoplastic agents 228159 2019-07 2020-05 Issued Notice of Compliance Erdafitinib Antineoplastic agents 224529 2019-03 2019-10 Issued Notice of Compliance under the NOC/c Guidance Erenumab Analgesics 208607 2017-10 2018-08 Issued Notice of Compliance Ertugliflozin pidolate Drugs used in diabetes 204724 2017-07 2018-05 Issued Notice of Compliance Ertugliflozin pidolate, metformin hydrochloride Drugs used in diabetes 201005 2017-08 2018-05 Issued Notice of Compliance Ertugliflozin pidolate, sitagliptin phosphate monohydrate Drugs used in diabetes 201006 2017-07 2018-05 Issued Notice of Compliance Esketamine hydrochloride Psychoanaleptics 222855 2019-01 2020-05 Issued Notice of Compliance Estradiol hemihydrate, progesterone Sex hormones and modulators of the genital system 224010 2019-11 2020-09 Issued Notice of Compliance Estriol, lactobacillus acidophilus Sex hormones and modulators of the genital system 203472 2017-06 2019-01 Issued a Notice of Deficiency-Withdrawal Etanercept Immunosuppressants 193864 2016-06 2017-04 Issued Notice of Compliance Etomidate Anesthetics 231245 2019-12 2020-07 Issued Notice of Compliance Etonogestrel Sex hormones and modulators of the genital system 226314 2019-05 2020-05 Issued Notice of Compliance Fedratinib dihydrochloride monohydrate Antineoplastic agents 229866 2019-10 2020-07 Issued Notice of Compliance Fibrinogen (human) Antihemorrhagics 195870 2016-08 2017-06 Issued Notice of Compliance Filgrastim (r-metHuG-CSF) Immunostimulants 212016 2018-02 2019-08 Cancelled by sponsor Filgrastim (r-metHuG-CSF) Immunostimulants 214080 2018-04 2020-04 Issued Notice of Compliance Flibanserin Other gynecologicals 189352 2016-04 2018-02 Issued Notice of Compliance Florbetaben (18F) Diagnostic radiopharmaceuticals 193105 2016-04 2017-02 Issued Notice of Compliance Fluocinolone acetonide Ophthalmologicals 201510 2017-02 2018-11 Issued Notice of Compliance Fluorouracil Antineoplastic agents 211768 2018-04 2019-02 Issued Notice of Compliance Fluoxetine hydrochloride Psychoanaleptics 198520 2016-12 2017-06 Issued Notice of Compliance Fluticasone furoate, umeclidinium bromide, vilanterol trifenatate Drugs for obstructive airway diseases 204880 2017-06 2018-04 Issued Notice of Compliance Fluticasone propionate Drugs for obstructive airway diseases 197873 2016-10 2017-08 Issued Notice of Compliance Fluticasone proprionate, salmeterol xinafoate Drugs for obstructive airway diseases 197974 2016-11 2018-04 Issued Notice of Compliance Follitropin delta Sex hormones and modulators of the genital system 188743 2016-01 2018-03 Issued Notice of Compliance Formoterol fumarate dihydrate, glycopyrronium bromide Drugs for obstructive airway diseases 201306 2017-02 2018-03 Issued Notice of Compliance Foscarnet sodium Antivirals for systemic use 233046 2019-12 2020-10 Issued Notice of Compliance Fosfomycin sodium Antibacterials for systemic use click to read 219662 2018-11 2019-05 Issued Notice of Compliance Fostamatinib disodium Antihemorrhagics 232078 2020-01 2020-11 Issued Notice of Compliance Fremanezumab Analgesics 226828 2019-06 2020-04 Issued Notice of Compliance Gadoteric acid Contrast media 186333 2015-12 2016-11 Issued Notice of Compliance Galcanezumab Analgesics 219521 2018-10 2019-07 Issued Notice of Compliance Gallium (68Ga) chloride Diagnostic radiopharmaceuticals 221824 2019-04 2019-11 Issued Notice of Compliance Gallium (68Ga) chloride, germanium (68Ge) chloride Diagnostic radiopharmaceuticals 227804 2019-10 2020-08 Issued Notice of Compliance Gemtuzumab ozogamicin Antineoplastic agents 223091 2019-02 2019-11 Issued Notice of Compliance Gilteritinib fumarate Antineoplastic agents 227918 2019-06 2019-12 Issued Notice 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Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B treatments 200726 2017-05 2019-03 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) treatments 203436 2017-04 2018-02 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) treatments 222669 2019-01 2019-11 Issued Notice of Compliance Haemagglutinin-strain A(H1N1), haemagglutinin-strain A(H3N2), haemagglutinin-strain B(Victoria), haemagglutinin-strain B(Yamagata) treatments 234113 2020-01 2020-11 Cancelled by sponsor Halobetasol propionate, tazarotene Corticosteroids, dermatological preparations 212718 2018-05 2020-06 Issued Notice of Compliance Hemin Other alimentary tract and metabolism 212276 2018-01 2018-07 Issued Notice of Compliance Human heterologous liver cells Other alimentary tract and metabolism products 205160 2017-06 2018-07 Cancelled by sponsor Hydrochlorothiazide, zofenopril calcium Agents acting on the renin-angiotensin system 212396 2018-06 2019-06 Cancelled by sponsor Hydrogen peroxide Other dermatological preparations 216854 2018-12 2019-08 Cancelled by sponsor Icosapent ethyl Lipid modifying agents 227235 2019-07 2019-12 Issued Notice of Compliance Idarucizumab All other therapeutic products 182503 2015-05 2016-04 Issued Notice of Compliance under the NOC/c Guidance Immunoglobulin (human) Immune sera and immunoglobulins 194291 2016-10 2017-08 Issued Notice of Compliance Immunoglobulin (human) Immune sera and immunoglobulins 226576 2019-06 2019-12 Issued Notice of Compliance Immunoglobulin G (human) Immune sera and immunoglobulins 202924 2017-04 2018-02 Issued Notice of Compliance Indacaterol acetate, mometasone furoate Drugs for obstructive airway diseases 227987 2019-07 2020-05 Issued Notice of Compliance Infliximab Immunosuppressants 226189 2019-05 2020-03 Issued Notice of Compliance Inotersen sodium Other nervous system drugs 214274 2018-04 2018-10 Issued Notice of Compliance Inotuzumab ozogamicin Antineoplastic agents 204077 2017-05 2018-03 Issued Notice of Compliance Insulin aspart Drugs used in diabetes 226573 2019-12 2020-10 Issued Notice of Compliance Insulin degludec Drugs used in diabetes 198124 2016-10 2017-08 Issued Notice of Compliance Insulin degludec, liraglutide Drugs used in diabetes 194513 2017-06 2018-04 Issued Notice of Compliance Insulin glargine Drugs used in diabetes 202772 2017-04 2019-02 Cancelled by sponsor Insulin glargine, lixisenatide Drugs used in diabetes 207006 2017-09 2018-07 Issued Notice of Compliance Insulin injection human biosynthetic Drugs used in diabetes 189076 2016-09 2017-07 Issued Notice of Compliance Insulin lispro Drugs used in diabetes 200792 2017-01 2017-11 Issued Notice of Compliance Iodine Contrast media 196107 2016-09 2017-07 Issued Notice of Compliance Ioflupane (123I) Diagnostic radiopharmaceuticals 201481 2017-02 2017-12 Issued Notice of Compliance Iron dextran Antianemic preparations 189897 2016-05 2017-06 Cancelled by sponsor Iron isomaltoside 1000 Antianemic preparations 193890 2016-07 2018-06 Issued Notice of Compliance Isatuximab Antineoplastic agents 229245 2019-07 2020-04 Issued Notice of Compliance Isavuconazonium sulfate Antimycotics for systemic use 208919 2018-02 2018-12 Issued Notice of Compliance Ivacaftor, tezacaftor Other respiratory system products 211292 2017-12 2018-06 Issued Notice of Compliance Ivermectin Anthelmintics 211000 2017-12 2018-09 Issued Notice of Compliance Ixazomib citrate Antineoplastic agents 190498 2016-02 2016-08 Issued Notice of Compliance Ixekizumab Immunosuppressants 184993 2015-07 2016-05 Issued Notice of Compliance Lanadelumab Other hematological agents 213920 2018-03 2018-09 Issued Notice of Compliance Larotrectinib Antineoplastic agents 219998 2018-11 2019-07 Issued Notice of Compliance under the NOC/c Guidance 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Guidance Luspatercept Antianemic preparations 236441 2020-03 2020-09 Issued Notice of Compliance Lutetium (177Lu) oxodotretotide Therapeutic radiopharmaceuticals 217184 2018-07 2019-01 Issued Notice of Compliance Mannitol Diagnostic agents 217446 2018-08 2019-06 Issued Notice of Compliance Mecasermin Pituitary, hypothalamic hormones and analogues 235023 2020-02 2020-12 Issued Notice of Compliance Meningococcal group A polysaccharide-tetanus toxoid conjugate, meningococcal group C polysaccharide-tetanus toxoid conjugate, meningococcal group W polysaccharide-tetanus toxoid conjugate, meningococcal group Y polysaccharide-tetanus toxoid conjugate treatments 233632 2020-01 2020-10 Issued Notice of Compliance Mercaptamine bitartrate Other alimentary tract and metabolism products 191347 2016-03 2017-06 Issued Notice of Compliance Mesalazine Antidiarrheals, intestinal anti-inflammatory/anti-infective agents 204605 2017-05 2018-03 Issued Notice of Compliance Mesalazine Antidiarrheals, 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2017-10 Issued Notice of Compliance Neratinib maleate Antineoplastic agents 218224 2018-09 2019-07 Issued Notice of Compliance Netupitant, palonosetron hydrochloride Antiemetics and antinauseants 196495 2016-12 2017-09 Issued Notice of Compliance Nicardipine hydrochloride Calcium channel blockers 216257 2018-07 2020-04 Issued Notice of Non-compliance - Withdrawal Niraparib Antineoplastic agents 216792 2018-09 2019-06 Issued Notice of Compliance Nitisinone Other alimentary tract and metabolism products 190564 2016-03 2016-09 Issued Notice of Compliance Nitisinone Other alimentary tract and metabolism products 193226 2016-07 2016-12 Issued Notice of Compliance Nitisinone Other alimentary tract and metabolism products 193770 2016-05 2016-11 Issued Notice of Compliance Nusinersen Other drugs for disorders of the musculo-skeletal systemOther 200070 2016-12 2017-06 Issued Notice of Compliance Obeticholic acid Bile and liver therapy 198418 2016-10 2017-05 Issued Notice of Compliance under the NOC/c Guidance Obiltoxaximab Immune sera and immunoglobulins 230825 2019-10 2020-07 Issued Notice of Compliance Ocrelizumab Immunosuppressants 198094 2016-10 2017-08 Issued Notice of Compliance Ocrelizumab Immunosuppressants 197969 2016-10 2018-02 Issued Notice of Compliance under the NOC/c Guidance Olaparib Antineoplastic agents 182823 2015-06 2016-04 Issued Notice of Compliance under the NOC/c Guidance Olaratumab Antineoplastic agents 203478 2017-04 2017-11 Issued Notice of Compliance under the NOC/c Guidance Onasemnogene abeparvovec Other drugs for disorders of the musculo-skeletal system 239719 2020-06 2020-12 Issued Notice of Compliance Osimertinib Antineoplastic agents 188171 2015-11 2016-07 Issued Notice of Compliance under the NOC/c Guidance Oxycodone Analgesics 198865 2016-11 2018-07 Cancelled by sponsor Ozanimod hydrochloride Immunosuppressants 232761 2019-12 2020-10 Issued Notice of Compliance Ozenoxacin Antibiotics and chemotherapy for dermatological use 192925 2016-07 2017-05 Issued Notice of Compliance Panobinostat Antineoplastic agents 187504 2015-11 2016-06 Cancelled by sponsor Patiromer sorbitex calcium All other therapeutic products 210368 2017-12 2018-10 Issued Notice of Compliance Patisiran Other nervous system drugs 221896 2018-12 2019-06 Issued Notice of Compliance Pegaspargase Antineoplastic agents 189795 2016-05 2017-02 Issued Notice of Compliance Pegfilgrastim Immunostimulants 204841 2017-06 2018-04 Issued Notice of Compliance Pegfilgrastim Immunostimulants 200807 2017-01 2018-12 Issued Notice of Compliance Pegfilgrastim Immunostimulants 220445 2019-05 2020-04 Issued Notice of Compliance Pegfilgrastim Immunostimulants 233373 2020-01 2020-10 Issued Notice of Compliance Peramivir Antivirals for systemic use 191280 2016-03 2017-01 Issued Notice of Compliance Perindopril arginine Agents acting on the renin-angiotensin system 201189 2017-08 2018-03 Issued Notice of Compliance Plecanatide Drugs for constipation 215288 2018-12 2019-10 Issued Notice of Compliance Polatuzumab vedotin Antineoplastic agents 232303 2019-11 2020-07 Issued Notice of Compliance under the NOC/c Guidance PrabotulinumtoxinA Muscle relaxants 208364 2017-10 2018-08 Issued Notice of Compliance Pralatrexate Antineoplastic agents 207545 2017-11 2018-10 Issued Notice of Compliance under the NOC/c Guidance Prasterone Anabolic agents for systemic use 198822 2016-12 2019-11 Issued Notice of Compliance Progesterone Sex hormones and modulators of the genital system 211548 2018-02 2018-08 Issued Notice of Compliance Propiverine hydrochloride Urologicals 188323 2016-03 2017-01 Issued Notice of Compliance Rabies immunoglobulin, human Immune sera and immunoglobulins 211541 2018-01 2018-11 Issued Notice of Compliance Ranolazine Cardiac therapy 239943 2020-07 2020-12 Issued Notice of Compliance Ravulizumab Immunosuppressants 217955 2018-11 2019-08 Issued Notice of Compliance Recombinant fusion protein linking factor IX with recombinant albumin (RIX-FP) Antihemorrhagics 180793 2015-04 2016-01 Issued Notice of Compliance Remdesivir Antivirals for systemic use 240551 2020-07 2020-07 Issued Notice of Compliance under the NOC/c Guidance Reslizumab Immunosuppressants 185873 2015-09 2016-07 Issued Notice of Compliance Ribociclib Antineoplastic agents 203884 2017-05 2018-03 Issued Notice of Compliance Ripretinib Antineoplastic agents 234688 2020-03 2020-06 Issued Notice of Compliance Risankizumab Immunosuppressants 215753 2018-06 2019-04 Issued Notice of Compliance Risperidone Psycholeptics 233331 2020-01 2020-11 Issued Notice of Compliance Rituximab Antineoplastic agents 207702 2017-09 2019-03 Cancelled by sponsor Rituximab Antineoplastic agents 208107 2017-09 2019-03 Cancelled by sponsor Rituximab Antineoplastic agents 208204 2017-09 2019-04 Issued Notice of Compliance Rituximab Antineoplastic agents 224672 2019-03 2019-04 Cancelled by sponsor Rituximab Antineoplastic agents 214058 2018-04 2020-04 Issued Notice of Compliance Rituximab Antineoplastic agents 224164 2019-03 2020-05 Issued Notice of Compliance Romosozumab Drugs for treatment of bone diseases 197713 2016-10 2019-06 Issued Notice of Compliance Rupatadine fumarate Antihistamines for systemic use 186488 2015-09 2016-07 Issued Notice of Compliance Safinamide Anti-parkinson drugs 207115 2018-03 2019-01 Issued Notice of Compliance Salbutamol sulfate Drugs for obstructive airway diseases 189577 2016-11 2017-11 Issued Notice of Compliance Sarilumab Immunosuppressants 191745 2016-03 2017-01 Issued Notice of Compliance Satralizumab Immunosuppressants 233642 2019-12 2020-06 Issued Notice of Compliance Sebelipase alfa Other alimentary tract and metabolism products 204085 2017-04 2017-12 Issued Notice of Compliance under the NOC/c Guidance Semaglutide Drugs used in diabetes 202059 2017-03 2018-01 Issued Notice of Compliance Semaglutide Drugs used in diabetes 226906 2019-06 2020-03 Issued Notice of Compliance Siponimod Immunosuppressants 223225 2019-02 2020-02 Issued 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Compliance Tisagenlecleucel-T Antineoplastic agents 213547 2018-03 2018-09 Issued Notice of Compliance Tisagenlecleucel-T Antineoplastic agents 213698 2018-03 2018-09 Issued Notice of Compliance Trastuzumab Antineoplastic agents 204579 2017-06 2019-05 Issued Notice of Compliance Trastuzumab Antineoplastic agents 212140 2018-02 2019-08 Issued Notice of Compliance Trastuzumab Antineoplastic agents 210238 2017-11 2019-09 Issued Notice of Compliance Trastuzumab Antineoplastic agents 208836 2017-10 2020-02 Issued Notice of Compliance Triamcinolone hexacetonide Corticosteroids for systemic use 201546 2017-02 2017-12 Issued Notice of Compliance Trientine hydrochloride Other alimentary tract and metabolism products 228708 2019-11 2020-09 Issued Notice of Compliance Trifarotene Anti-acne preparations 221945 2019-01 2019-11 Issued Notice of Compliance Tucatinib Antineoplastic agents 235295 2020-02 2020-06 Issued Notice of Compliance Upadacitinib Immunosuppressants 223734 2019-03 2019-12 Issued Notice of Compliance Varicella-zoster ventolin glycoprotein E (GE) treatments 200244 2016-12 2017-10 Issued Notice of Compliance Venetoclax Antineoplastic agents 190761 2016-02 2016-09 Issued Notice of Compliance under the NOC/c Guidance Vernakalant hydrochloride Cardiac therapy 190817 2016-05 2017-03 Issued Notice of Compliance Volanesorsen Lipid modifying agents 209280 2017-11 2018-11 Issued Notice of Non-compliance - Withdrawal Vonicog alfa Antihemorrhagics 213188 2018-03 2019-01 Issued Notice of Compliance Voretigene neparvovec Ophthalmologicals 233097 2019-12 2020-10 Issued Notice of Compliance Zofenopril calcium Agents acting on the renin-angiotensin system 212392 2018-06 2019-06 Cancelled by sponsor.

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About This TrackerThis tracker provides the number of confirmed cases and deaths from novel asthma by country, the trend in confirmed case and death counts ventolin liquid for babies by country, and a global map showing which find out countries have confirmed cases and deaths. The data are drawn from the Johns Hopkins University ventolin liquid for babies (JHU) asthma Resource Center’s asthma treatment Map and the World Health Organization’s (WHO) asthma Disease (asthma treatment-2019) situation reports.This tracker will be updated regularly, as new data are released.Related Content. About asthma treatment asthmaIn late 2019, a new asthma emerged in central China to cause disease in humans. Cases of this disease, known as asthma treatment, have since been reported across around the globe ventolin liquid for babies.

On January 30, 2020, the World Health Organization (WHO) declared the ventolin represents a public health emergency of international concern, and on January 31, 2020, the U.S. Department of Health and Human Services declared it to be a health emergency for the United States.With schools nationwide preparing for fall and the federal government encouraging in-person classes, key concerns for school officials, teachers and parents include the risks that asthma poses to children and ventolin liquid for babies their role in transmission of the disease.A new KFF brief examines the latest available data and evidence about the issues around asthma treatment and children and what they suggest about the risks posed for reopening classrooms. The review concludes that ventolin liquid for babies while children are much less likely than adults to become severely ill, they can transmit the ventolin. Key findings include:Disease severity is significantly less in children, though rarely some do get very sick.

Children under age 18 account for 22% of the population but account for just 7% of the more than 4 million asthma treatment cases and less than 1% of deaths.The evidence is mixed about whether children are less likely than adults to become infected when exposed ventolin liquid for babies. While one prominent study estimates children and teenagers are half as likely as adults over age 20 to catch the ventolin, other studies find children and adults are about equally likely to have antibodies that develop after a asthma treatment .While children do transmit to others, more evidence is needed on the frequency and extent of that transmission. A number of studies find children are less likely ventolin liquid for babies than adults to be the source of s in households and other settings, though this could occur because of differences in testing, the severity of the disease, and the impact of earlier school closures.Most countries that have reopened schools have not experienced outbreaks, but almost all had significantly lower rates of community transmission. Some countries, including Canada, Chile, France, and Israel did experience school-based outbreaks, sometimes significant ones, that required schools to close a second time.The analysis concludes that there is a risk of spread associated with reopening schools, particularly in states and communities where there is already widespread community transmission, that should be weighed carefully against the benefits of in-person education..

About This TrackerThis tracker provides the number of confirmed cases and deaths from novel asthma by country, the trend in confirmed case how to get ventolin online and death counts by country, and a global map showing which countries have confirmed cases and deaths. The data are drawn from the Johns Hopkins University (JHU) asthma Resource how to get ventolin online Center’s asthma treatment Map and the World Health Organization’s (WHO) asthma Disease (asthma treatment-2019) situation reports.This tracker will be updated regularly, as new data are released.Related Content. About asthma treatment asthmaIn late 2019, a new asthma emerged in central China to cause disease in humans. Cases of this disease, known how to get ventolin online as asthma treatment, have since been reported across around the globe. On January 30, 2020, the World Health Organization (WHO) declared the ventolin represents a public health emergency of international concern, and on January 31, 2020, the U.S.

Department of Health and Human Services declared it to be a health emergency for the United States.With schools nationwide preparing for fall and the federal government encouraging in-person classes, key concerns for school officials, teachers and parents include the risks that asthma poses to children and their role in transmission of the disease.A new KFF brief examines how to get ventolin online the latest available data and evidence about the issues around asthma treatment and children and what they suggest about the risks posed for reopening classrooms. The review concludes that while children are much less likely than adults to become severely ill, they how to get ventolin online can transmit the ventolin. Key findings include:Disease severity is significantly less in children, though rarely some do get very sick. Children under age 18 account for 22% of the population but account for just 7% of the more than 4 million asthma treatment cases and less than 1% of deaths.The evidence is mixed about whether children are less likely than adults to become infected when how to get ventolin online exposed. While one prominent study estimates children and teenagers are half as likely as adults over age 20 to catch the ventolin, other studies find children and adults are about equally likely to have antibodies that develop after a asthma treatment .While children do transmit to others, more evidence is needed on the frequency and extent of that transmission.

A number of studies find children are less likely than adults to be the source of s in households and other settings, though this could occur because of differences in testing, the severity of the disease, and the impact of earlier school how to get ventolin online closures.Most countries that have reopened schools have not experienced outbreaks, but almost all had significantly lower rates of community transmission. Some countries, including Canada, Chile, France, and Israel did experience school-based outbreaks, sometimes significant ones, that required schools to close a second time.The analysis concludes that there is a risk of spread associated with reopening schools, particularly in states and communities where there is already widespread community transmission, that should be weighed carefully against the benefits of in-person education..

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See the find out here now SUPPLEMENTARY can you buy ventolin over the counter in australia INFORMATION Start Printed Page 74347section for electronic access to the Authorization. Start Further Info Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.

1, Rm can you buy ventolin over the counter in australia. 4332, Silver Spring, MD 20993-0002, 301-796-8510 (this is not a toll free number). End Further Info End Preamble Start Supplemental Information I.

Background Section can you buy ventolin over the counter in australia 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations.

With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a biological, can you buy ventolin over the counter in australia chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds. (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents.

(2) a determination by can you buy ventolin over the counter in australia the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. Military forces, including personnel operating under the authority of title 10 or title 50 of the U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents.

Or (B) an agent or agents that may cause, or are otherwise associated can you buy ventolin over the counter in australia with, an imminently life-threatening and specific risk to U.S. Military forces; [] (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. Citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents.

Or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health can you buy ventolin over the counter in australia Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. Citizens living abroad.

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product can you buy ventolin over the counter in australia if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use.

Products appropriate for emergency use may include products and can you buy ventolin over the counter in australia uses that are not approved, cleared, or licensed under section 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C.

360ccc). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA [] concludes. (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition.

(2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition. Or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent. And (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable.

(3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition. (4) in the case of a determination described in section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense. And (5) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. III. Electronic Access An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​emergency-use-authorization.

IV. The Authorizations Having concluded that the criteria for the issuance and, in some cases reissuance, of the following Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of the following products for diagnosing, treating, or preventing asthma treatment subject to the terms of each Authorization. The Authorizations in their entirety, including any authorized fact sheets and other written materials, are available on the internet from the FDA web page entitled “Emergency Use Authorization,” available at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​emergency-use-authorization.

The lists that follow include Authorizations issued, in some cases reissued, from May 16, 2020, through September 14, 2020, and we have included explanations of the reasons for their issuance, as required by section 564(h)(1) of the FD&C Act. FDA is hereby announcing the following Authorizations for molecular diagnostic Start Printed Page 74348and antigen tests for asthma treatment, excluding multianalyte tests: [] Color Genomics, Inc.'s Color asthma LAMP Diagnostic Assay, issued May 18, 2020, and reissued July 24, 2020. Quidel Corp.'s Lyra Direct asthma Assay, issued May 18, 2020.

P23 Labs, LLC's P23 Labs TaqPath SARSd-CoV-2 Assay, issued May 21, 2020, and reissued July 10, 2020. SEASUN BIOMATERIALS, Inc.'s AQ-TOP asthma treatment Rapid Detection Kit, issued May 21, 2020. SolGent Co., Ltd.'s DiaPlexQ Novel asthma (2019-nCoV) Detection Kit, issued May 21, 2020.

BioCore Co., Ltd.'s BioCore 2019-nCoV Real Time PCR Kit, issued May 21, 2020. Exact Sciences Laboratories' SARSd-CoV-2 (N gene detection) Test, issued May 22, 2020, and reissued August 3, 2020. Dba SpectronRx's Hymon SARSd-CoV-2 Test Kit, issued May 22, 2020.

PrivaPath Diagnostics, Inc.'s LetsGetChecked asthma (asthma treatment) Test, issued May 28, 2020, and reissued August 14, 2020. Gravity Diagnostics, LLC's Gravity Diagnostics asthma treatment Assay, issued June 1, 2020. Phosphorus Diagnostics LLC's Phosphorus asthma treatment RT-qPCR Test, issued June 4, 2020.

Genetron Health (Beijing) Co., Ltd.'s Genetron SARSd-CoV-2 RNA Test, issued June 5, 2020. Euroimmun US Inc.'s EURORealTime SARSd-CoV-2, issued June 8, 2020. ChromaCode Inc.'s HDPCR SARSd-CoV-2 Assay, issued June 9, 2020.

Illumina, Inc.'s Illumina asthma treatmentSeq Test, issued June 9, 2020. Tide Laboratories, LLC's DTPM asthma treatment RT-PCR Test, issued June 10, 2020. TBG Biotechnology Corp.'s ExProbe SARSd-CoV-2 Testing Kit, issued June 10, 2020.

Cue Health, Inc.'s Cue asthma treatment Test, issued June 10, 2020. RTA Laboratories Biological Products Pharmaceutical and Machinery Industry's Diagnovital SARSd-CoV-2 Real-Time PCR Kit, issued June 12, 2020. Kaiser Permanente Mid-Atlantic States's KPMAS asthma treatment Test, issued June 13, 2020, and reissued September 9, 2020.

Applied BioCode, Inc.'s BioCode SARSd-CoV-2 Assay, issued June 15, 2020. The Ohio State University Wexner Medical Center's OSUWMC asthma treatment RT-PCR test, issued June 17, 2020. Omnipathology Solutions Medical Corp.'s Omni asthma treatment Assay by RT-PCR, issued June 17, 2020.

Jiangsu Bioperfectus Technologies Co., Ltd.'s asthma treatment asthma Real Time PCR Kit, issued June 18, 2020. 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.'s TRUPCR SARSd-CoV-2 Kit, issued June 18, 2020. HealthQuest Esoterics's HealthQuest Esoterics TaqPath SARSd-CoV-2 Assay, issued June 23, 2020.

University of Alabama at Birmingham Fungal Reference Lab's FRL SARS CoV-2 Test, issued June 23, 2020. Gencurix, Inc.'s GenePro SARSd-CoV-2 Test, issued June 23, 2020. University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory's MD Anderson High-throughput SARSd-CoV-2 RT-PCR Assay, issued June 24, 2020.

Diagnostic Solutions Laboratory, LLC's DSL asthma treatment Assay, issued June 25, 2020. PreciGenome LLC's FastPlex Triplex SARSd-CoV-2 detection kit (RT-Digital PCR), issued June 25, 2020. PlexBio Co., Ltd.'s IntelliPlex SARSd-CoV-2 Detection Kit, issued June 25, 2020.

Inform Diagnostics, Inc.'s Inform Diagnostics SARSd-CoV-2 RT-PCR Assay, issued June 26, 2020. Acupath Laboratories, Inc.'s Acupath asthma treatment Real-Time (RT-PCR) Assay, issued June 29, 2020. LifeHope Labs' LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, issued June 29, 2020.

Psomagen, Inc.'s Psoma asthma treatment RT Test, issued June 30, 2020. TNS Co., Ltd.'s (Bio TNS) asthma treatment RT-PCR Peptide Nucleic Acid (PNA) kit, issued June 30, 2020. The Kroger Co.'s Kroger Health asthma treatment Test Home Collection Kit, issued June 30, 2020.

CENTOGENE US, LLC's CentoFast-SARSd-CoV-2 RT-PCR Assay, issued July 1, 2020. Becton, Dickinson and Co.'s BD Veritor System for Rapid Detection of SARSd-CoV-2, issued July 2, 2020. Laboratorio Clinico Toledo's Laboratorio Clinico Toledo SARSd-CoV-2 Assay, issued July 6, 2020.

Gene By Gene's Gene By Gene SARSd-CoV-2 Detection Test, issued July 7, 2020. Access Bio, Inc.'s CareStart asthma treatment MDx RT-PCR, issued July 7, 2020. Enzo Life Sciences, Inc.'s AMPIPROBE SARSd-CoV-2 Test System, issued July 7, 2020.

Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard's CRSP SARSd-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay, issued July 8, 2020. BioSewoom, Inc.'s Real-Q 2019-nCoV Detection Kit, issued July 9, 2020. UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin's SARSd-CoV-2 RNA DETECTR Assay, issued July 9, 2020.

Boston Medical Center's BMC-CReM asthma treatment Test, issued July 10, 2020. KogeneBiotech Co., Ltd.'s PowerChek 2019-nCoV Real-time PCR Kit, issued July 13, 2020. Trax Management Services Inc.'s PhoenixDx SARSd-CoV-2 Multiplex, issued July 13, 2020.

Compass Laboratory Services, LLC's Compass Laboratory Services SARSd-CoV2 Assay, issued July 13, 2020. Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics PF SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics RC SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020.

Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics HA SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Boston Heart Diagnostics' Boston Heart asthma treatment RT-PCR Test, issued July 16, 2020. Access Genetics, LLC's OraRisk asthma treatment RT-PCR, issued July 17, 2020.

DiaCarta, Inc.'s Quantiventolin SARSd-CoV-2 Multiplex Test Kit, issued July 21, 2020. Helix OpCo LLC's (dba Helix's) Helix asthma treatment Test, issued July 23, 2020. Jiangsu CoWin Biotech Co., Ltd.'s Novel asthma (SARSd-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing), issued July 24, 2020.

LabCorp's asthma treatment RT-PCR Test, reissued July 24, 2020 (original issuance March 16, 2020). Eli Lilly and Co.'s Lilly SARSd-CoV-2 Assay, issued July 27, 2020;Start Printed Page 74349 Sandia National Laboratories' SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay, issued July 27, 2020. Clinical Reference Laboratory, Inc.'s CRL Rapid Response, issued July 30, 2020.

University of California San Diego Health's UCSD RC SARSd-CoV-2 Assay, issued July 31, 2020. Xiamen Zeesan Biotech Co., Ltd.'s SARSd-CoV-2 Test Kit (Real-time PCR), issued July 31, 2020. ISPM Labs, LLC dba Capstone Healthcare's Genus SARSd-CoV-2 Assay, issued August 3, 2020.

Poplar Healthcare's Poplar SARSd-CoV-2 TMA Pooling assay, issued August 3, 2020. Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute's Cleveland Clinic SARSd-CoV-2 Assay, issued August 3, 2020.

Ethos Laboratories' Ethos Laboratories SARSd-CoV-2 MALDI-TOF Assay, issued August 3, 2020. Wren Laboratories LLC's Wren Laboratories asthma treatment PCR Test, issued August 3, 2020. Vela Operations Singapore Pte Ltd.'s ViroKey SARSd-CoV-2 RT-PCR Test, issued August 5, 2020.

Helix OpCo LLC's (dba Helix) Helix asthma treatment NGS Test, issued August 6, 2020. George Washington University Public Health Laboratory's GWU SARSd-CoV-2 RT-PCR Test, issued August 7, 2020. Quest Diagnostics Infectious Disease, Inc.'s SARSd-CoV-2 RNA, Qualitative Real-Time RT-PCR, reissued August 7, 2020 (original issuance March 17, 2020).

Alpha Genomix Laboratories' Alpha Genomix TaqPath SARSd-CoV-2 Combo Assay, issued August 10, 2020. Solaris Diagnostics' Solaris Multiplex SARSd-CoV-2 Assay, issued August 10, 2020. Biomeme, Inc.'s Biomeme SARSd-CoV-2 Real-Time RT-PCR Test, issued August 11, 2020.

LumiraDx UK Ltd.'s LumiraDx asthma RNA STAR, issued August 11, 2020. Pro-Lab Diagnostics' Pro-AmpRT SARSd-CoV-2 Test, issued August 13, 2020. Yale School of Public Health, Department of Epidemiology of Microbial Diseases' SalivaDirect, issued August 15, 2020, and reissued August 28, 2020.

ZhuHai Sinochips Bioscience Co., Ltd.'s asthma treatment Nucleic Acid RT-PCR Test Kit, issued August 17, 2020. LumiraDx UK Ltd.'s LumiraDx SARSd-CoV-2 Ag Test, issued August 18, 2020. Assurance Scientific Laboratories' Assurance SARSd-CoV-2 Panel, reissued August 19, 2020 (original issuance May 15, 2020).

Guardant Health, Inc.'s Guardant-19, issued August 21, 2020. DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT-PCR Test, issued August 21, 2020. Texas Department of State Health Services, Laboratory Services Section's Texas Department of State Health Services SARSd-CoV-2 Assay, issued August 21, 2020.

Fluidigm Corp.'s Advanta Dx SARSd-CoV-2 RT-PCR Assay, issued August 25, 2020. QDx Pathology Services' QDX SARSd-CoV-2 Assay, issued August 25, 2020. Cuur Diagnostics' Cuur Diagnostics SARSd-CoV-2 Molecular Assay, issued August 26, 2020.

Abbott Diagnostics Scarborough, Inc.'s BinaxNOW asthma treatment Ag Card, issued August 26, 2020. Patients Choice Laboratories, LLC's PCL SARSd-CoV-2 Real-Time RT-PCR Assay, issued August 28, 2020. DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT PCR CE Test, issued August 28, 2020.

T2 Biosystems, Inc.'s T2SARSd-CoV-2 Panel, issued August 31, 2020. MiraDx's MiraDx SARSd-CoV-2 RT-PCR assay, issued August 31, 2020. Mammoth Biosciences, Inc.'s SARSd-CoV-2 DETECTR Reagent Kit, issued August 31, 2020.

BayCare Laboratories, LLC's BayCare SARSd-CoV-2 RT PCR Assay, issued August 31, 2020. Detectachem Inc.'s MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit, issued September 1, 2020. OPTOLANE Technologies, Inc.'s Kaira 2019-nCoV Detection Kit, issued September 1, 2020.

Bioeksen R&D Technologies Ltd.'s Bio-Speedy Direct RT-qPCR SARSd-CoV-2, issued September 2, 2020. BillionToOne, Inc.'s qSanger-asthma treatment Assay, issued September 4, 2020. Verily Life Sciences' Verily asthma treatment RT-PCR Test, issued September 8, 2020.

And Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s Wantai SARSd-CoV-2 RT-PCR Kit, issued September 9, 2020. FDA is hereby announcing the following Authorizations for serology tests: [] Healgen Scientific LLC's asthma treatment IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), issued May 29, 2020. Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-CoV-2 Total (COV2T), issued May 29, 2020.

Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-CoV-2 Total (COV2T), issued May 29, 2020. Hangzhou Biotest Biotech Co., Ltd.'s RightSign asthma treatment IgG/IgM Rapid Test Cassette, issued June 4, 2020. Vibrant America Clinical Labs' Vibrant asthma treatment Ab Assay, issued June 4, 2020.

Siemens Healthcare Diagnostics Inc.'s Dimension Vista SARSd-CoV-2 Total antibody assay (COV2T), issued June 8, 2020. Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARSd-CoV-2 Total antibody assay (CV2T), issued June 8, 2020. InBios International, Inc.'s SCoV-2 Detect IgG ELISA [enzyme-linked immunosorbent assay], issued June 10, 2020.

Cellex Inc.'s qSARSd-CoV-2 IgG/IgM Rapid Test, reissued June 12, 2020 (original issuance April 1, 2020). Emory Medical Laboratories' SARSd-CoV-2 RBD IgG test, issued June 15, 2020. Biohit Healthcare (Hefei) Co.

Ltd.'s Biohit SARSd-CoV-2 IgM/IgG Antibody Test Kit, issued June 18, 2020. Hangzhou Laihe Biotech Co., Ltd.'s LYHER Novel asthma (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), issued June 19, 2020. Babson Diagnostics, Inc.'s Babson Diagnostics aC19G1, issued June 23, 2020.

Beckman Coulter, Inc.'s Access SARSd-CoV-2 IgG, issued June 26, 2020. InBios International, Inc.'s SCoV-2 Detect IgM ELISA, issued June 30, 2020. Assure Tech.'s (Hangzhou Co., Ltd.) Assure asthma treatment IgG/IgM Rapid Test Device, issued July 6, 2020.

Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2 IgG CLIA Kit, issued July 8, 2020. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s WANTAI SARSd-CoV-2 Ab Rapid Test, July 10, 2020;Start Printed Page 74350 Salofa Oy's Sienna-Clarity COVIBLOCK asthma treatment IgG/IgM Rapid Test Cassette, issued July 13, 2020. Luminex Corp.'s xMAP SARSd-CoV-2 Multi-Antigen IgG Assay, issued July 16, 2020.

Megna Health, Inc.'s Rapid asthma treatment IgM/IgG Combo Test Kit, issued July 17, 2020. Access Bio, Inc.'s CareStart asthma treatment IgM/IgG, issued July 24, 2020. Xiamen Biotime Biotechnology Co., Ltd.'s BIOTIME SARSd-CoV-2 IgG/IgM Rapid Qualitative Test, issued July 24, 2020.

Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-CoV-2 IgG (COV2G), issued July 31, 2020. Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-CoV-2 IgG (COV2G), issued July 31, 2020. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s WANTAI SARSd-CoV-2 Ab ELISA, issued August 5, 2020.

BioMérieux SA's VIDAS SARSd-CoV-2 IgM, issued August 6, 2020. BioMérieux SA's VIDAS SARSd-CoV-2 IgG, issued August 6, 2020. Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2 IgM CLIA Kit, issued August 17, 2020.

BioCheck, Inc.'s BioCheck SARSd-CoV-2 IgG and IgM Combo Test, issued August 17, 2020. Biocan Diagnostics Inc.'s Tell Me Fast Novel asthma (asthma treatment) IgG/IgM Antibody Test, issued August 25, 2020. TBG Biotechnology Corp.'s TBG SARSd-CoV-2 IgG/IgM Rapid Test Kit, issued August 31, 2020.

University of Arizona Genetics Core for Clinical Services' asthma treatment ELISA pan-Ig Antibody Test, issued August 31, 2020. Sugentech, Inc.'s SGTi-flex asthma treatment IgG, issued September 3, 2020. BioCheck, Inc.'s BioCheck asthma IgG Antibody Test Kit, issued September 9, 2020.

BioCheck, Inc.'s BioCheck asthma IgM Antibody Test Kit, issued September 9, 2020. And Shenzhen New Industries Biomedical Engineering Co., Ltd.'s MAGLUMI 2019-nCoV IgM/IgG, issued September 14, 2020. FDA is hereby announcing the following Authorizations for multianalyte in vitro diagnostics: [] Centers for Disease Control and Prevention's Influenza asthma (Flu SC2) Multiplex Assay, issued July 2, 2020.

Roche Molecular Systems, Inc.'s cobas asthma &. Influenza A/B, issued September 3, 2020. And Roche Molecular Systems, Inc.'s cobas asthma &.

Influenza A/B Nucleic Acid Test for use on the cobas Liat System, issued September 14, 2020. FDA is hereby announcing the following Authorizations for personal respiratory protective devices: [] FDA is hereby announcing the following Authorizations for other medical devices. Baxter Healthcare Corp.'s Prismaflex ST Set, issued May 20, 2020; [] STERIS Corp.'s AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle, issued May 21, 2020; [] Certain Gowns and Other Apparel, issued May 22, 2020; [] CLEW Medical Ltd.'s CLEWICU System, issued May 26, 2020; [] Abiomed, Inc.'s Impella RP System, issued May 29, 2020; [] Start Printed Page 74351 Roche Diagnostics' Elecsys IL-6, issued on June 2, 2020; [] Battelle Memorial Institute's Battelle CCDS Critical Care Decontamination System (“Batelle Decontamination System”), reissued June 6, 2020 [] (original issuance March 29, 2020).

STERIS Corp.'s STERIS Sterilization System, reissued June 6, 2020 [] (original issuance April 9, 2020). Stryker Instruments' STERIZONE VP4 N95 Respirator Decontamination Cycle, reissued June 6, 2020 [] (original issuance on April 14, 2020). Advanced Sterilization Products, Inc.'s (ASP) STERRAD 100S, NX, and 100NX Sterilization Systems (“ASP STERRAD Sterilization Systems”), reissued June 6, 2020 [] (original issuance April 11, 2020).

Stryker Sustainability Solutions' (SSS) SSS VHP N95 Respirator Decontamination System, issued May 27, 2020, reissued June 6, 2020; [] Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (“Sterilucent Sterilization System”), reissued June 6, 2020 [] (original issuance April 20, 2020). Duke University Health System's Duke Decontamination System for Decontamination and Reuse of N95 Respirators with Hydrogen Peroxide Vapor (“Duke Decontamination System”), reissued June 6, 2020 [] (original issuance May 7, 2020). Technical Safety Services LLC's 20-CS Decontamination System, issued June 13, 2020; [] Oceanetics, Inc.'s Negative-pressure Respiratory System with Advanced Ventilation Return (“NRSAVR-100”), issued June 13, 2020; [] US Army and MHS's asthma treatment Airway Management Isolation Chamber (CAMIC), issued May 19, 2020 and reissued to US Army Medical Research Development Command June 22, 2020; [] Start Printed Page 74352 electroCore, Inc.'s gammaCore Sapphire CV, issued July 10, 2020; [] Michigan State University Animal Care Program's MSU Decontamination System, issued July 24, 2020; [] IkonX, Inc.'s Airway Dome, issued July 24, 2020; [] Abiomed, Inc.'s Impella Left Ventricular (LV) Support Systems, issued August 3, 2020; [] Baxter Healthcare Corp.'s Prismaflex HF20 Set, issued August 10, 2020; [] NovaSterilis, Inc.'s Nova2200 using the NovaClean decontamination process for decontaminating compatible N95 respirators, issued August 20, 2020; [] and Color Genomics, Inc.'s Color asthma treatment Self-Swab Collection Kit, issued August 31, 2020.[] Start Signature Dated.

November 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information [FR Doc. 2020-25603 Filed 11-19-20. 8:45 am]BILLING CODE 4164-01-PBy Kelsie George Rural residents across the U.S.

May be at higher risk for severe illness from asthma treatment due to the aging population, higher rates of underlying chronic disease, and higher likelihood of having a disability. Combined with limited health care infrastructure and greater travel times to access in-person care, these challenges limit access to critical health care for the approximately 20% of Americans that live in rural communities. Today, Nov.

19, is National Rural Health Day, an annual celebration of rural communities and their success in addressing their unique challenges in accessing and delivering health care services. This day is an opportunity to recognize the positive things that are taking place in rural health. For example, amid the asthma treatment ventolin, states are ensuring access to quality health care for rural residents through several policy strategies—such as bolstering telehealth services and supporting rural hospitals and health facilities.

Bolstering Telehealth Access and Coverage Patients and providers are seeking opportunities to access and deliver health care services during the asthma treatment public health crisis. Bolstering telehealth access and coverage is one way states are enhancing access to care, especially for large rural populations. On the payment front.

Colorado required Medicaid reimbursement for telehealth services at the same rate as in-person services for Rural Health Clinics, federal Indian Health Service facilities, and Federally Qualified Health Centers. Florida appropriated $4 million to implement a pilot project to provide behavioral telehealth services to children in public schools, with a focus on rural communities. Michigan expanded originating sites (the patient’s location during a telehealth visit) to include in-home and in-school settings.

In part to ensure access to telehealth services, Mississippi authorized grant funding for the asthma treatment Broadband Provider Grant Program Fund to expand rural broadband capacity and facilitate telemedicine, remote work and distance learning. Supporting Rural Hospitals and Health Facilities Health care infrastructure presents a challenge for rural communities given the potentially long distances to health facilities, the large geographic areas health facilities serve, and the shortage of health professionals in rural regions. Many of these barriers to access are exacerbated by the asthma treatment ventolin.

To address increasing rural hospital closures, Georgia established the Rural Center for Health Care Innovation in 2018 to evaluate the health data workforce data and develop mandatory Hospital Board and Executive Leadership Training, which has trained more than 250 rural hospital leaders to date. Georgia also increased appropriations in 2020 for the Rural Hospital Stabilization Program (originally established in 2014) from $3 million to $15 million. Washington exempted Rural Health Clinics from the state’s Certificate of Need review process if they provide services in designated home health shortage areas within the state.

While many of these issues are not new, state legislatures continue to explore options and opportunities to prevent the spread of asthma treatment and ensure access to care for rural populations across the country.

4338, Silver buy ventolin over the counter australia Spring, how to get ventolin online MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION Start Printed Page 74347section for electronic access to the Authorization. Start Further Info Jennifer how to get ventolin online J.

Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-8510 (this is how to get ventolin online not a toll free number). End Further Info End Preamble Start Supplemental Information I.

Background Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections how to get ventolin online against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives.

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Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents. Or (B) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. Military forces; [] (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public how to get ventolin online health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. Citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents.

Or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security how to get ventolin online or the health and security of U.S. Citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied.

Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation how to get ventolin online of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under section 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or section 351 of the PHS how to get ventolin online Act (42 U.S.C.

262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes how to get ventolin online of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA [] concludes. (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition.

(2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition. Or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an how to get ventolin online agent. And (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable. (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.

(4) in the case of a determination described in section 564(b)(1)(B)(ii), how to get ventolin online that the request for emergency use is made by the Secretary of Defense. And (5) that such other criteria as may be prescribed by regulation are satisfied. No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. III.

Electronic Access An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​emergency-use-authorization. IV. The Authorizations Having concluded that the criteria for the issuance and, in some cases reissuance, of the following Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of the following products for diagnosing, treating, or preventing asthma treatment subject to the terms of each Authorization. The Authorizations in their entirety, including any authorized fact sheets and other written materials, are available on the internet from the FDA web page entitled “Emergency Use Authorization,” available at https://www.fda.gov/​emergency-preparedness-and-response/​mcm-legal-regulatory-and-policy-framework/​emergency-use-authorization.

The lists that follow include Authorizations issued, in some cases reissued, from May 16, 2020, through September 14, 2020, and we have included explanations of the reasons for their issuance, as required by section 564(h)(1) of the FD&C Act. FDA is hereby announcing the following Authorizations for molecular diagnostic Start Printed Page 74348and antigen tests for asthma treatment, excluding multianalyte tests: [] Color Genomics, Inc.'s Color asthma LAMP Diagnostic Assay, issued May 18, 2020, and reissued July 24, 2020. Quidel Corp.'s Lyra Direct asthma Assay, issued May 18, 2020. P23 Labs, LLC's P23 Labs TaqPath SARSd-CoV-2 Assay, issued May 21, 2020, and reissued July 10, 2020.

SEASUN BIOMATERIALS, Inc.'s AQ-TOP asthma treatment Rapid Detection Kit, issued May 21, 2020. SolGent Co., Ltd.'s DiaPlexQ Novel asthma (2019-nCoV) Detection Kit, issued May 21, 2020. BioCore Co., Ltd.'s BioCore 2019-nCoV Real Time PCR Kit, issued May 21, 2020. Exact Sciences Laboratories' SARSd-CoV-2 (N gene detection) Test, issued May 22, 2020, and reissued August 3, 2020.

Dba SpectronRx's Hymon SARSd-CoV-2 Test Kit, issued May 22, 2020. PrivaPath Diagnostics, Inc.'s LetsGetChecked asthma (asthma treatment) Test, issued May 28, 2020, and reissued August 14, 2020. Gravity Diagnostics, LLC's Gravity Diagnostics asthma treatment Assay, issued June 1, 2020. Phosphorus Diagnostics LLC's Phosphorus asthma treatment RT-qPCR Test, issued June 4, 2020.

Genetron Health (Beijing) Co., Ltd.'s Genetron SARSd-CoV-2 RNA Test, issued June 5, 2020. Euroimmun US Inc.'s EURORealTime SARSd-CoV-2, issued June 8, 2020. ChromaCode Inc.'s HDPCR SARSd-CoV-2 Assay, issued June 9, 2020. Illumina, Inc.'s Illumina asthma treatmentSeq Test, issued June 9, 2020.

Tide Laboratories, LLC's DTPM asthma treatment RT-PCR Test, issued June 10, 2020. TBG Biotechnology Corp.'s ExProbe SARSd-CoV-2 Testing Kit, issued June 10, 2020. Cue Health, Inc.'s Cue asthma treatment Test, issued June 10, 2020. RTA Laboratories Biological Products Pharmaceutical and Machinery Industry's Diagnovital SARSd-CoV-2 Real-Time PCR Kit, issued June 12, 2020.

Kaiser Permanente Mid-Atlantic States's KPMAS asthma treatment Test, issued June 13, 2020, and reissued September 9, 2020. Applied BioCode, Inc.'s BioCode SARSd-CoV-2 Assay, issued June 15, 2020. The Ohio State University Wexner Medical Center's OSUWMC asthma treatment RT-PCR test, issued June 17, 2020. Omnipathology Solutions Medical Corp.'s Omni asthma treatment Assay by RT-PCR, issued June 17, 2020.

Jiangsu Bioperfectus Technologies Co., Ltd.'s asthma treatment asthma Real Time PCR Kit, issued June 18, 2020. 3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.'s TRUPCR SARSd-CoV-2 Kit, issued June 18, 2020. HealthQuest Esoterics's HealthQuest Esoterics TaqPath SARSd-CoV-2 Assay, issued June 23, 2020. University of Alabama at Birmingham Fungal Reference Lab's FRL SARS CoV-2 Test, issued June 23, 2020.

Gencurix, Inc.'s GenePro SARSd-CoV-2 Test, issued June 23, 2020. University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory's MD Anderson High-throughput SARSd-CoV-2 RT-PCR Assay, issued June 24, 2020. Diagnostic Solutions Laboratory, LLC's DSL asthma treatment Assay, issued June 25, 2020. PreciGenome LLC's FastPlex Triplex SARSd-CoV-2 detection kit (RT-Digital PCR), issued June 25, 2020.

PlexBio Co., Ltd.'s IntelliPlex SARSd-CoV-2 Detection Kit, issued June 25, 2020. Inform Diagnostics, Inc.'s Inform Diagnostics SARSd-CoV-2 RT-PCR Assay, issued June 26, 2020. Acupath Laboratories, Inc.'s Acupath asthma treatment Real-Time (RT-PCR) Assay, issued June 29, 2020. LifeHope Labs' LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel, issued June 29, 2020.

Psomagen, Inc.'s Psoma asthma treatment RT Test, issued June 30, 2020. TNS Co., Ltd.'s (Bio TNS) asthma treatment RT-PCR Peptide Nucleic Acid (PNA) kit, issued June 30, 2020. The Kroger Co.'s Kroger Health asthma treatment Test Home Collection Kit, issued June 30, 2020. CENTOGENE US, LLC's CentoFast-SARSd-CoV-2 RT-PCR Assay, issued July 1, 2020.

Becton, Dickinson and Co.'s BD Veritor System for Rapid Detection of SARSd-CoV-2, issued July 2, 2020. Laboratorio Clinico Toledo's Laboratorio Clinico Toledo SARSd-CoV-2 Assay, issued July 6, 2020. Gene By Gene's Gene By Gene SARSd-CoV-2 Detection Test, issued July 7, 2020. Access Bio, Inc.'s CareStart asthma treatment MDx RT-PCR, issued July 7, 2020.

Enzo Life Sciences, Inc.'s AMPIPROBE SARSd-CoV-2 Test System, issued July 7, 2020. Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard's CRSP SARSd-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay, issued July 8, 2020. BioSewoom, Inc.'s Real-Q 2019-nCoV Detection Kit, issued July 9, 2020. UCSF Health Clinical Laboratories, UCSF Clinical Labs at China Basin's SARSd-CoV-2 RNA DETECTR Assay, issued July 9, 2020.

Boston Medical Center's BMC-CReM asthma treatment Test, issued July 10, 2020. KogeneBiotech Co., Ltd.'s PowerChek 2019-nCoV Real-time PCR Kit, issued July 13, 2020. Trax Management Services Inc.'s PhoenixDx SARSd-CoV-2 Multiplex, issued July 13, 2020. Compass Laboratory Services, LLC's Compass Laboratory Services SARSd-CoV2 Assay, issued July 13, 2020.

Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics PF SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics RC SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Quest Diagnostics Infectious Disease, Inc.'s Quest Diagnostics HA SARSd-CoV-2 Assay, issued July 15, 2020, and reissued August 21, 2020. Boston Heart Diagnostics' Boston Heart asthma treatment RT-PCR Test, issued July 16, 2020.

Access Genetics, LLC's OraRisk asthma treatment RT-PCR, issued July 17, 2020. DiaCarta, Inc.'s Quantiventolin SARSd-CoV-2 Multiplex Test Kit, issued July 21, 2020. Helix OpCo LLC's (dba Helix's) Helix asthma treatment Test, issued July 23, 2020. Jiangsu CoWin Biotech Co., Ltd.'s Novel asthma (SARSd-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing), issued July 24, 2020.

LabCorp's asthma treatment RT-PCR Test, reissued July 24, 2020 (original issuance March 16, 2020). Eli Lilly and Co.'s Lilly SARSd-CoV-2 Assay, issued July 27, 2020;Start Printed Page 74349 Sandia National Laboratories' SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay, issued July 27, 2020. Clinical Reference Laboratory, Inc.'s CRL Rapid Response, issued July 30, 2020. University of California San Diego Health's UCSD RC SARSd-CoV-2 Assay, issued July 31, 2020.

Xiamen Zeesan Biotech Co., Ltd.'s SARSd-CoV-2 Test Kit (Real-time PCR), issued July 31, 2020. ISPM Labs, LLC dba Capstone Healthcare's Genus SARSd-CoV-2 Assay, issued August 3, 2020. Poplar Healthcare's Poplar SARSd-CoV-2 TMA Pooling assay, issued August buy ventolin pill 3, 2020. Cleveland Clinic Robert J.

Tomsich Pathology and Laboratory Medicine Institute's Cleveland Clinic SARSd-CoV-2 Assay, issued August 3, 2020. Ethos Laboratories' Ethos Laboratories SARSd-CoV-2 MALDI-TOF Assay, issued August 3, 2020. Wren Laboratories LLC's Wren Laboratories asthma treatment PCR Test, issued August 3, 2020. Vela Operations Singapore Pte Ltd.'s ViroKey SARSd-CoV-2 RT-PCR Test, issued August 5, 2020.

Helix OpCo LLC's (dba Helix) Helix asthma treatment NGS Test, issued August 6, 2020. George Washington University Public Health Laboratory's GWU SARSd-CoV-2 RT-PCR Test, issued August 7, 2020. Quest Diagnostics Infectious Disease, Inc.'s SARSd-CoV-2 RNA, Qualitative Real-Time RT-PCR, reissued August 7, 2020 (original issuance March 17, 2020). Alpha Genomix Laboratories' Alpha Genomix TaqPath SARSd-CoV-2 Combo Assay, issued August 10, 2020.

Solaris Diagnostics' Solaris Multiplex SARSd-CoV-2 Assay, issued August 10, 2020. Biomeme, Inc.'s Biomeme SARSd-CoV-2 Real-Time RT-PCR Test, issued August 11, 2020. LumiraDx UK Ltd.'s LumiraDx asthma RNA STAR, issued August 11, 2020. Pro-Lab Diagnostics' Pro-AmpRT SARSd-CoV-2 Test, issued August 13, 2020.

Yale School of Public Health, Department of Epidemiology of Microbial Diseases' SalivaDirect, issued August 15, 2020, and reissued August 28, 2020. ZhuHai Sinochips Bioscience Co., Ltd.'s asthma treatment Nucleic Acid RT-PCR Test Kit, issued August 17, 2020. LumiraDx UK Ltd.'s LumiraDx SARSd-CoV-2 Ag Test, issued August 18, 2020. Assurance Scientific Laboratories' Assurance SARSd-CoV-2 Panel, reissued August 19, 2020 (original issuance May 15, 2020).

Guardant Health, Inc.'s Guardant-19, issued August 21, 2020. DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT-PCR Test, issued August 21, 2020. Texas Department of State Health Services, Laboratory Services Section's Texas Department of State Health Services SARSd-CoV-2 Assay, issued August 21, 2020. Fluidigm Corp.'s Advanta Dx SARSd-CoV-2 RT-PCR Assay, issued August 25, 2020.

QDx Pathology Services' QDX SARSd-CoV-2 Assay, issued August 25, 2020. Cuur Diagnostics' Cuur Diagnostics SARSd-CoV-2 Molecular Assay, issued August 26, 2020. Abbott Diagnostics Scarborough, Inc.'s BinaxNOW asthma treatment Ag Card, issued August 26, 2020. Patients Choice Laboratories, LLC's PCL SARSd-CoV-2 Real-Time RT-PCR Assay, issued August 28, 2020.

DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT PCR CE Test, issued August 28, 2020. T2 Biosystems, Inc.'s T2SARSd-CoV-2 Panel, issued August 31, 2020. MiraDx's MiraDx SARSd-CoV-2 RT-PCR assay, issued August 31, 2020. Mammoth Biosciences, Inc.'s SARSd-CoV-2 DETECTR Reagent Kit, issued August 31, 2020.

BayCare Laboratories, LLC's BayCare SARSd-CoV-2 RT PCR Assay, issued August 31, 2020. Detectachem Inc.'s MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit, issued September 1, 2020. OPTOLANE Technologies, Inc.'s Kaira 2019-nCoV Detection Kit, issued September 1, 2020. Bioeksen R&D Technologies Ltd.'s Bio-Speedy Direct RT-qPCR SARSd-CoV-2, issued September 2, 2020.

BillionToOne, Inc.'s qSanger-asthma treatment Assay, issued September 4, 2020. Verily Life Sciences' Verily asthma treatment RT-PCR Test, issued September 8, 2020. And Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s Wantai SARSd-CoV-2 RT-PCR Kit, issued September 9, 2020. FDA is hereby announcing the following Authorizations for serology tests: [] Healgen Scientific LLC's asthma treatment IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), issued May 29, 2020.

Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-CoV-2 Total (COV2T), issued May 29, 2020. Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-CoV-2 Total (COV2T), issued May 29, 2020. Hangzhou Biotest Biotech Co., Ltd.'s RightSign asthma treatment IgG/IgM Rapid Test Cassette, issued June 4, 2020. Vibrant America Clinical Labs' Vibrant asthma treatment Ab Assay, issued June 4, 2020.

Siemens Healthcare Diagnostics Inc.'s Dimension Vista SARSd-CoV-2 Total antibody assay (COV2T), issued June 8, 2020. Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARSd-CoV-2 Total antibody assay (CV2T), issued June 8, 2020. InBios International, Inc.'s SCoV-2 Detect IgG ELISA [enzyme-linked immunosorbent assay], issued June 10, 2020. Cellex Inc.'s qSARSd-CoV-2 IgG/IgM Rapid Test, reissued June 12, 2020 (original issuance April 1, 2020).

Emory Medical Laboratories' SARSd-CoV-2 RBD IgG test, issued June 15, 2020. Biohit Healthcare (Hefei) Co. Ltd.'s Biohit SARSd-CoV-2 IgM/IgG Antibody Test Kit, issued June 18, 2020. Hangzhou Laihe Biotech Co., Ltd.'s LYHER Novel asthma (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), issued June 19, 2020.

Babson Diagnostics, Inc.'s Babson Diagnostics aC19G1, issued June 23, 2020. Beckman Coulter, Inc.'s Access SARSd-CoV-2 IgG, issued June 26, 2020. InBios International, Inc.'s SCoV-2 Detect IgM ELISA, issued June 30, 2020. Assure Tech.'s (Hangzhou Co., Ltd.) Assure asthma treatment IgG/IgM Rapid Test Device, issued July 6, 2020.

Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2 IgG CLIA Kit, issued July 8, 2020. Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s WANTAI SARSd-CoV-2 Ab Rapid Test, July 10, 2020;Start Printed Page 74350 Salofa Oy's Sienna-Clarity COVIBLOCK asthma treatment IgG/IgM Rapid Test Cassette, issued July 13, 2020. Luminex Corp.'s xMAP SARSd-CoV-2 Multi-Antigen IgG Assay, issued July 16, 2020. Megna Health, Inc.'s Rapid asthma treatment IgM/IgG Combo Test Kit, issued July 17, 2020.

Access Bio, Inc.'s CareStart asthma treatment IgM/IgG, issued July 24, 2020. Xiamen Biotime Biotechnology Co., Ltd.'s BIOTIME SARSd-CoV-2 IgG/IgM Rapid Qualitative Test, issued July 24, 2020. Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-CoV-2 IgG (COV2G), issued July 31, 2020. Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-CoV-2 IgG (COV2G), issued July 31, 2020.

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s WANTAI SARSd-CoV-2 Ab ELISA, issued August 5, 2020. BioMérieux SA's VIDAS SARSd-CoV-2 IgM, issued August 6, 2020. BioMérieux SA's VIDAS SARSd-CoV-2 IgG, issued August 6, 2020. Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2 IgM CLIA Kit, issued August 17, 2020.

BioCheck, Inc.'s BioCheck SARSd-CoV-2 IgG and IgM Combo Test, issued August 17, 2020. Biocan Diagnostics Inc.'s Tell Me Fast Novel asthma (asthma treatment) IgG/IgM Antibody Test, issued August 25, 2020. TBG Biotechnology Corp.'s TBG SARSd-CoV-2 IgG/IgM Rapid Test Kit, issued August 31, 2020. University of Arizona Genetics Core for Clinical Services' asthma treatment ELISA pan-Ig Antibody Test, issued August 31, 2020.

Sugentech, Inc.'s SGTi-flex asthma treatment IgG, issued September 3, 2020. BioCheck, Inc.'s BioCheck asthma IgG Antibody Test Kit, issued September 9, 2020. BioCheck, Inc.'s BioCheck asthma IgM Antibody Test Kit, issued September 9, 2020. And Shenzhen New Industries Biomedical Engineering Co., Ltd.'s MAGLUMI 2019-nCoV IgM/IgG, issued September 14, 2020.

FDA is hereby announcing the following Authorizations for multianalyte in vitro diagnostics: [] Centers for Disease Control and Prevention's Influenza asthma (Flu SC2) Multiplex Assay, issued July 2, 2020. Roche Molecular Systems, Inc.'s cobas asthma &. Influenza A/B, issued September 3, 2020. And Roche Molecular Systems, Inc.'s cobas asthma &.

Influenza A/B Nucleic Acid Test for use on the cobas Liat System, issued September 14, 2020. FDA is hereby announcing the following Authorizations for personal respiratory protective devices: [] FDA is hereby announcing the following Authorizations for other medical devices. Baxter Healthcare Corp.'s Prismaflex ST Set, issued May 20, 2020; [] STERIS Corp.'s AMSCO Medium Steam Sterilizers + the STERIS STEAM Decon Cycle, issued May 21, 2020; [] Certain Gowns and Other Apparel, issued May 22, 2020; [] CLEW Medical Ltd.'s CLEWICU System, issued May 26, 2020; [] Abiomed, Inc.'s Impella RP System, issued May 29, 2020; [] Start Printed Page 74351 Roche Diagnostics' Elecsys IL-6, issued on June 2, 2020; [] Battelle Memorial Institute's Battelle CCDS Critical Care Decontamination System (“Batelle Decontamination System”), reissued June 6, 2020 [] (original issuance March 29, 2020). STERIS Corp.'s STERIS Sterilization System, reissued June 6, 2020 [] (original issuance April 9, 2020).

Stryker Instruments' STERIZONE VP4 N95 Respirator Decontamination Cycle, reissued June 6, 2020 [] (original issuance on April 14, 2020). Advanced Sterilization Products, Inc.'s (ASP) STERRAD 100S, NX, and 100NX Sterilization Systems (“ASP STERRAD Sterilization Systems”), reissued June 6, 2020 [] (original issuance April 11, 2020). Stryker Sustainability Solutions' (SSS) SSS VHP N95 Respirator Decontamination System, issued May 27, 2020, reissued June 6, 2020; [] Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide Sterilizer (“Sterilucent Sterilization System”), reissued June 6, 2020 [] (original issuance April 20, 2020). Duke University Health System's Duke Decontamination System for Decontamination and Reuse of N95 Respirators with Hydrogen Peroxide Vapor (“Duke Decontamination System”), reissued June 6, 2020 [] (original issuance May 7, 2020).

Technical Safety Services LLC's 20-CS Decontamination System, issued June 13, 2020; [] Oceanetics, Inc.'s Negative-pressure Respiratory System with Advanced Ventilation Return (“NRSAVR-100”), issued June 13, 2020; [] US Army and MHS's asthma treatment Airway Management Isolation Chamber (CAMIC), issued May 19, 2020 and reissued to US Army Medical Research Development Command June 22, 2020; [] Start Printed Page 74352 electroCore, Inc.'s gammaCore Sapphire CV, issued July 10, 2020; [] Michigan State University Animal Care Program's MSU Decontamination System, issued July 24, 2020; [] IkonX, Inc.'s Airway Dome, issued July 24, 2020; [] Abiomed, Inc.'s Impella Left Ventricular (LV) Support Systems, issued August 3, 2020; [] Baxter Healthcare Corp.'s Prismaflex HF20 Set, issued August 10, 2020; [] NovaSterilis, Inc.'s Nova2200 using the NovaClean decontamination process for decontaminating compatible N95 respirators, issued August 20, 2020; [] and Color Genomics, Inc.'s Color asthma treatment Self-Swab Collection Kit, issued August 31, 2020.[] Start Signature Dated. November 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

End Signature End Supplemental Information [FR Doc. 2020-25603 Filed 11-19-20. 8:45 am]BILLING CODE 4164-01-PBy Kelsie George Rural residents across the U.S. May be at higher risk for severe illness from asthma treatment due to the aging population, higher rates of underlying chronic disease, and higher likelihood of having a disability.

Combined with limited health care infrastructure and greater travel times to access in-person care, these challenges limit access to critical health care for the approximately 20% of Americans that live in rural communities. Today, Nov. 19, is National Rural Health Day, an annual celebration of rural communities and their success in addressing their unique challenges in accessing and delivering health care services. This day is an opportunity to recognize the positive things that are taking place in rural health.

For example, amid the asthma treatment ventolin, states are ensuring access to quality health care for rural residents through several policy strategies—such as bolstering telehealth services and supporting rural hospitals and health facilities. Bolstering Telehealth Access and Coverage Patients and providers are seeking opportunities to access and deliver health care services during the asthma treatment public health crisis. Bolstering telehealth access and coverage is one way states are enhancing access to care, especially for large rural populations. On the payment front.

Colorado required Medicaid reimbursement for telehealth services at the same rate as in-person services for Rural Health Clinics, federal Indian Health Service facilities, and Federally Qualified Health Centers. Florida appropriated $4 million to implement a pilot project to provide behavioral telehealth services to children in public schools, with a focus on rural communities. Michigan expanded originating sites (the patient’s location during a telehealth visit) to include in-home and in-school settings. In part to ensure access to telehealth services, Mississippi authorized grant funding for the asthma treatment Broadband Provider Grant Program Fund to expand rural broadband capacity and facilitate telemedicine, remote work and distance learning.

Supporting Rural Hospitals and Health Facilities Health care infrastructure presents a challenge for rural communities given the potentially long distances to health facilities, the large geographic areas health facilities serve, and the shortage of health professionals in rural regions. Many of these barriers to access are exacerbated by the asthma treatment ventolin. To address increasing rural hospital closures, Georgia established the Rural Center for Health Care Innovation in 2018 to evaluate the health data workforce data and develop mandatory Hospital Board and Executive Leadership Training, which has trained more than 250 rural hospital leaders to date. Georgia also increased appropriations in 2020 for the Rural Hospital Stabilization Program (originally established in 2014) from $3 million to $15 million.

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