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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- November 09, 2023: FDA Clears First COVID-19 Home Antigen Test.
- November 03, 2023: FDA Roundup including FDA announcement of its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns.
- November 03, 2023: FDA Roundup including the revision of the EUA for Paxlovid to facilitate the transition from the U.S. government’s distribution of Paxlovid labeled for use under the EUA to Pfizer’s distribution of the commercial (NDA-labeled) Paxlovid.
- October 31, 2023: FDA Roundup including FDA acceptance of the first master file for the Radiation Sterilization Master File Pilot Program, a voluntary pilot program intended to help contract sterilizers and medical device manufacturers make changes — or advance alternative ways — to the way they sterilize FDA-approved medical devices.
- October 27, 2023: FDA Roundup including FDA clearance of Alltest Fentanyl Urine Test Cassette, the first over the counter test for the preliminary detection of fentanyl in urine.
- October 24, 2023: FDA Roundup including a Safety Alert advising restaurants and retailers not to serve or sell and consumers not to eat oysters from Future Seafoods, Inc., Prince Edward Island, Canada, from harvest area PE9B on 10/10/2023, and shipped to importers in FL, MA, MD, ME, PA, and VA, due to the possible presence of Salmonella and E. coli.
- October 20, 2023: FDA Roundup including the authorization of an extension for the shelf life of Gohibic (vilobelimab) for specific lots, from 24 months to 30 months. Gohibic is currently authorized for emergency use to treat COVID-19 in certain hospitalized adults.
- October 17, 2023: FDA Roundup including an announcement that the CDR is soliciting public comments to understand the state of innovation in clinical trial design and conduct.
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FDA Clears First COVID-19 Home Antigen Test
- On November 09, 2023, FDA cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19.
- ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18.
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Revised EUA for Paxlovid
- On November 01, 2023, FDA revised the EUA for Paxlovid to facilitate the transition from the U.S. government’s distribution of Paxlovid labeled for use under the EUA to Pfizer’s distribution of the commercial (NDA-labeled) Paxlovid.
- The FDA has updated the frequently asked questions about Paxlovid during this transition period and encourages people to visit the HHS Paxlovid landing page for additional information.
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Emergency Use Authorization (EUA) updates
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Information for industry and health care providers
Expiration date extension
Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions.
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In case you missed it
Quick COVID-19 resources
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What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 450 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
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FDA Medical Countermeasures Initiative (MCMi) News)
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