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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- June 14, 2023: It's not too late to join us for the FDA Science Forum! Today's sessions include medical countermeasures, infectious diseases, and pathogen reduction technologies. (Live webcast of the MCM session, starting at 9:00 a.m. ET.)
- June 13, 2023: FDA Roundup including an announcement that Guidance for Industry (GFI) #263 has been fully implemented (see Antimicrobial Resistance update below)
- June 12, 2023: BearCare, Inc. Recalls Rechargeable Walnut Wearable Smart Thermometers for Risks of Serious Injury, including Burns, During Use
- June 9, 2023: FDA Roundup including an update to the Medical Device Shortages List
- June 6, 2023: Annual report (PDF) to Congress on drug shortages (2022)
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Antimicrobial resistance update
FDA announces transition of over-the-counter medically important antimicrobials for animals to prescription status
FDA announced that Guidance for Industry (GFI) #263 has been fully implemented and all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. The successful implementation of GFI #263 is an encouraging demonstration of the commitment of animal drug sponsors and veterinarians to support the judicious use of antimicrobials in animals. (June 12, 2023)
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Emergency Use Authorization (EUA) updates
EUA quick links
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 Events
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June 13-14, 2023: FDA Science Forum (virtual) - Topic areas include medical countermeasures, infectious disease and pathogen reduction technologies, and product development and manufacturing, including advanced manufacturing. View the agenda, and register now to attend, and to receive post-event info. Don't miss 200+ posters about FDA research!
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June 15, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual, live on YouTube 8:30 a.m. ET) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination campaign. This discussion will include consideration of the vaccine composition for fall to winter, 2023-2024. Meeting materials are now available.
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June 20, 2023: Decentralized Clinical Trials (DCT) Draft Guidance webinar (3:00 - 4:00 p.m. ET)
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
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Information for industry and health care providers
Letter to Health Care Providers: Oxygenator Devices Used for Extracorporeal Circulation
FDA provided information to health care providers and facilities on oxygenator devices used in extracorporeal circulation. FDA issued this letter to help ensure that health care providers and facilities are aware of a recall notice by Getinge/Maquet for Quadrox Oxygenators and have information about alternative devices. (June 9, 2023)
Reminder - FDA announces additional steps to modernize clinical trials
FDA announced availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections. The updates are intended to help pave the way for more efficient clinical trials to facilitate the development of medical products. FDA is requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial types and data sources. Submit comments by September 6, 2023. (June 6, 2023)
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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)
Schedule note: The next edition of this newsletter will be the week of June 26, 2023, then every other week.
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