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Coronavirus Disease 2019 (COVID-19) updates
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Actions by FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
- January 29, 2021: COVID-19 Update including an import alert for all alcohol-based hand sanitizers from Mexico; warning letters issued jointly with the Federal Trade Commission to two companies selling unapproved products with fraudulent COVID-19 claims; and updated COVID-19 frequently asked questions
Bookmark www.fda.gov/coronavirus for the latest.
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 Q: Can the FDA help me get a COVID-19 vaccine?
A: No. The FDA’s authority includes authorizing or approving COVID-19 vaccines for use in the United States, but the FDA is not responsible for vaccine distribution. Go to the CDC website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. All questions and concerns should be sent to your state government or local health department. The U.S. government’s goal is to have enough COVID-19 vaccine doses for all people in the United States who choose to be vaccinated.
If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam. The Federal Trade Commission has easy tips on how to avoid COVID-19 vaccine scams. The FDA encourages you to report a potential COVID-19 drug or medical product scam on our website.
Related links:
FDA approves radiation treatment
On January 28, 2021, FDA approved a treatment to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). For more information about this treatment, please see the NPLATE (romiplostim) product label (PDF).
Related link:
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Emergency Use Authorization (EUA) updates
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Diagnostic test EUAs
As of today, 320 tests and sample collection devices are authorized by FDA under EUAs. These include 238 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 1 antigen prescription at-home test, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics
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Events
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Today! February 3, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on February 10, 17, and 24, 2021.
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February 23, 2021: Save the date for the next webinar in the series Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic,12:00 - 1:00 p.m. ET.
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May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD.
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Information for industry
Updated guidance on coagulation systems for measurement of viscoelastic properties
FDA adds content about medical products authorized for emergency use to guidance on clinical trials of medical products during COVID-19
- FDA has added content to the question-and-answer appendix in its guidance, Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency. The updated guidance includes a new question-and-answer regarding whether FDA considers receipt of medical products authorized under an EUA for use in clinical care, such as a vaccine to prevent COVID-19 or a monoclonal antibody to treat COVID-19, to be receipt of “investigational” medical products. This information may be relevant when sponsors are considering eligibility criteria that exclude patients from enrolling in clinical trials if they have received certain medical products. (January 27, 2021)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 70 COVID-19-related guidances to date.
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In case you missed it
COVID-19 vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 225 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.
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FDA Medical Countermeasures Initiative (MCMi) News)
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