The latest from FDA
COVID-19 vaccine updates
Advanced manufacturing update
OCET Advanced Manufacturing Program
Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. The OCET Advanced Manufacturing Program aims to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience.
The Office of Counterterrorism and Emerging Threats (OCET), in the Office of the Chief Scientist, published a new website section with additional information about its advanced manufacturing program, including new pages about the I-TEAM Hub collaboration with HHS/ASPR, a smart design and manufacturing pilot program, and a partnership with the National Institute of Standards and Technology (NIST) to develop and benchmark methods to predict thermal stability of monoclonal antibodies. The section also includes new pages about advanced manufacturing research and projects, and public-private partnerships. The existing Advanced Manufacturing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA. (November 21, 2022)
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 Regulatory science funding
FDA Broad Agency Announcement (BAA) Day agenda now available
On November 14, 2022, FDA posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For more information and areas of interest, including medical countermeasures and advanced manufacturing, see the full BAA PDF (788 KB).
We invite interested applicants to join us for FDA BAA Day on December 6, 2022, to learn more about the application process. A draft agenda is now available.
Events
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November 30, 2022: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and Monkeypox) (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. FDA will hold an additional event in this series on December 14, 2022.
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December 6, 2022: Save the date for FDA Broad Agency Announcement Day (webinar) to learn more about how FDA funds research, the types of projects we’re looking for to support regulatory science and innovation, and how you can apply.
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December 7-8, 2022: FDA Clinical Investigator Training Course (CITC) 2022 (webinar) - To promote professionalism in the clinical trial industry for individuals involved with FDA submissions (Investigational New Drug (IND) Application, New Drug Application (NDA), Biologic License Application (BLA), and Investigational Device Exemption (IDE)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical products.
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December 7-8, 2022: The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023 (virtual public workshop) - To provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share their perspectives on DSCSA implementation.
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December 8, 2022: Blood Products Advisory Committee meeting (virtual) - The committee will meet in open session to hear an overview of the research programs of the Laboratory of Emerging Pathogens and the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research.
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New! December 16, 2022: Machine Learning in Distributed Data Networks like the FDA Sentinel System: Opportunities, Challenges, and Considerations (12:30 - 1:30 p.m. ET, virtual).
In case you missed it
8 days until Thanksgiving!
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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It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!) |
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 280 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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Find additional updates on our website and in the Medical Countermeasures Initiative newsletter.
Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity
"Creating a world where health equity is a reality for all." www.fda.gov/healthequity
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