Coronavirus Disease 2019 (COVID-19) updates  Updates from FDA in our ongoing response to the COVID-19 pandemic since our last email update include: - January 25, 2022: FDA Roundup including authorization of another over-the-counter COVID-19 antigen test and updates to FDA web pages on In Vitro Diagnostics EUAs for Molecular and Antigen Diagnostic Tests for SARS-CoV-2
- January 24, 2022: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
- January 22, 2022: New web page: At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions
- January 21, 2022: FDA Takes Actions to Expand Use of Treatment for Outpatients with Mild-to-Moderate COVID-19
- January 21, 2022: FDA Roundup including an extension of previously announced temporary changes to inspectional activities to ensure the safety of FDA employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant
- January 21, 2022: The web page Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 is now available in Spanish and Simplified Chinese.
- January 19, 2022: UPDATE: Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel
Bookmark www.fda.gov/coronavirus for the latest. | COVID-19 treatment updates FDA takes actions to expand use of treatment for outpatients with mild-to-moderate COVID-19 FDA took two actions to expand the use of the antiviral drug Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease. This provides another treatment option to reduce the risk of hospitalization in high-risk patients. Previously, the use of Veklury was limited to patients requiring hospitalization. FDA has expanded the approved (PDF) indication for Veklury to include its use in adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. FDA also revised the Emergency Use Authorization (EUA) for Veklury (PDF) to additionally authorize the drug for treatment of pediatric patients weighing 3.5 kilograms to less than 40 kilograms or pediatric patients less than 12 years of age weighing at least 3.5 kilograms, with positive results of direct SARS-CoV-2 viral testing, and who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. (January 21, 2022) Health care providers should review this letter (PDF) for important prescribing information. FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the omicron variant As we have throughout the COVID-19 pandemic, FDA has used the best available science as the virus has evolved to make informed decisions with the health and safety of the American public in mind. Ensuring that health care providers on the frontlines have the best tools available to treat patients is a top priority for the agency. In light of the most recent information and data available, on January 24, 2022, FDA revised the EUAs for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) (PDF) and REGEN-COV (casirivimab and imdevimab) (PDF) – to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions. At-home diagnostic test updates Frequently asked questions Diagnostic tests can show if you have an active COVID-19 infection and need to take steps to quarantine or isolate yourself from others. Visit our new web page for answers to frequently asked questions related to at-home COVID-19 diagnostic tests, including "Can I use an authorized at-home COVID-19 diagnostic test if it was left outside in freezing temperatures?" (Briefly, yes: Bring the test to room temperature for at least 2 hours before using it and check that the test line(s) appear as described in the instructions. Read the full answer.) FDA authorizes another COVID-19 OTC test based on data from the NIH ITAP On January 19, 2022, FDA authorized (PDF) another over-the-counter (OTC) COVID-19 antigen test, where validation data were gathered through the FDA's collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The MaximBio ClearDetect COVID-19 Antigen Home Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. The test can be used as: - A single test for people with COVID-19 symptoms.
- A serial test for people without symptoms, meaning the test is done two times over three days.
The test can be used for people: - Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
Events - January 26, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host additional events in this series on February 9 and 23, 2022.
- February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
- New! March 3, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2022-2023 influenza season.
- March 7-9, 2022: FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
- April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
In case you missed it It's a good time to get your flu vaccine Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. | |  | Why you should not use ivermectin to treat or prevent COVID-19 Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages. | |  | List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 250 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list. | |  | Find additional coronavirus disease 2019 (COVID-19) updates on our website and in the Medical Countermeasures Initiative newsletter. Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity "Creating a world where health equity is a reality for all." www.fda.gov/healthequity  |
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