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The latest from FDA
 MCMi program update
Annual report on FDA's work to support medical countermeasure-related public health preparedness and response efforts
Today, FDA published the Medical Countermeasures Initiative (MCMi) Program Update report, which showcases FDA's work each year to prepare for all types of public health emergencies. Covering fiscal year 2022, the report includes updates on FDA's work agency-wide to support development of and access to medical countermeasures for a variety of public health threats, including COVID-19 and mpox. Download a printable PDF. (February 15, 2023)
Work with us
Job opening: Regulatory Counsel (Title 21, Cures Band C)
Apply to join the FDA Office of Counterterrorism and Emerging Threats (OCET) in the position of Regulatory Counsel, offering legal, regulatory, and policy expertise to help support medical countermeasure development and availability. For more information, see the job posting (PDF). Applications are due by February 24, 2023.
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Emergency Use Authorization (EUA) updates
New mpox point of care test
FDA issued an EUA (PDF) for the Cepheid Xpert Mpox test for use in a point-of-care (POC) setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The Xpert Mpox test is a real-time polymerase chain reaction (PCR) test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider. For more information, see: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices. (February 10, 2023)
COVID-19 in vitro diagnostic (test) EUAs
As of February 14, 2023, 444 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 58 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 43 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,228 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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February 15, 2023: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov.
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February 17, 2023: Application of Artificial Intelligence and Machine Learning for Precision Medicine (virtual) - Hosted in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), this workshop will review current methodologies, opportunities, challenges, and best practices to address the rapidly changing landscape of artificial intelligence and machine learning in the setting of drug development and precision medicine. Advance registration required.
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February 28-March 1, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of two respiratory syncytial virus (RSV) vaccine Biologics License Applications (BLAs).
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New! March 7, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - 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 2023--2024 influenza season.
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New! March 9, 2023: FDA Grand Rounds: Microphysiological Systems as Novel Disease Models and Drug Development Tools - This presentation by researchers from FDA's National Center for Toxicological Research (NCTR) evaluates nonhuman primate testicular organoids for use as an in vitro model of Zika virus infection.
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New! March 28-29, 2023: Public Workshop: Understanding Priorities for the Development of Digital Health Technologies to Support Clinical Trials for Drug Development and Review (virtual) - Hosted by FDA and the Duke-Robert J. Margolis, MD Center for Health Policy, to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcomes measures using DHTs.
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April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual) - Save the date! Registration will open in February 2023.
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New! May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual) - To provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. Seating is limited and will be available on a first come, first served basis. Attendees can indicate their interest to attend in person during the free registration for this workshop and are encouraged to register early.
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Information for industry and health care providers
FDA updates draft guidance to help increase supply of children’s ibuprofen
FDA has revised the immediately-in-effect guidance on compounding certain ibuprofen oral suspension products. The revision addresses outsourcing facilities providing certain ibuprofen oral suspension products to state-licensed pharmacies (including those within hospitals and health systems) and applicable federal facilities to dispense to patients for home use, following receipt of a valid, patient-specific prescription from a health care provider. FDA published this revision to address continual increased demand for fever and pain-reducing medications outside of hospitals and health systems. (February 9, 2023)
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 75 COVID-19-related guidances to date.
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In case you missed it
Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 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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