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Coronavirus Disease 2019 (COVID-19) updates
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Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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 New video: Beware of fraudulent coronavirus tests, vaccines and treatments
There are currently no FDA-approved drugs or vaccines to treat or prevent COVID-19. Products that fraudulently claim to cure, treat, diagnose, or prevent COVID-19 haven’t been evaluated by the FDA for safety and effectiveness for such use, and they might be dangerous to you and your family. Here are some tips to help you spot these fraudulent products. (September 21, 2020)
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Emergency Use Authorization (EUA) updates
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Reissued EUA for Abbott ID Now COVID-19 test
FDA reissued the EUA (PDF) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.” For additional details, see the September 18, 2020 Daily Roundup. (September 17, 2020)
Diagnostic test EUAs
As of today, 249 tests are authorized by FDA under EUAs; these include 199 molecular tests, 46 antibody tests, and 4 antigen tests Also see: Coronavirus Testing Basics
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Events
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Today! September 23, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SAR-CoV-2, 12:15 p.m. - 1:15 p.m. ET. FDA will host additional town halls in this series on Wednesdays in September. To ensure you are connected, please dial-in at 12:00 p.m.
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September 29, 2020: Save the date for the next event in FDA's webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available.
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October 2, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss and make recommendations on selection of strains to be included in an influenza virus vaccine for the 2021 Southern Hemisphere influenza season, which is part of FDA’s year-round efforts to flight flu, along with other public health partners like CDC and NIH.
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October 22, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting.
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Information for industry
Drugs and biologics
- FDA added content to the question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. This guidance is intended for industry, investigators, and institutional review boards. The updated guidance includes a new question-and-answer regarding a clinical trial investigator’s responsibility to review all investigational new drug application safety reports, including reports that will not result in a change to the investigator brochure, informed consent, or protocol. (September21, 2020)
The 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 60 COVID-19-related guidances to date.
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In case you missed it
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 175 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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Donate COVID-19 plasma
If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma.
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COVID-19 resources for health professionals
Find information about medical products FDA has authorized for emergency use, frequently asked questions about personal protective equipment (PPE), resources to share with your patients, and more.
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