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COVID-19 vaccine updates
Monkeypox response updates
New diagnostic test EUA
FDA issued an EUA (PDF) to Roche Molecular Systems, Inc. for the cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (EUA220459) for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of monkeypox virus infection by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity tests. (November 15, 2022) Also see: Monkeypox Emergency Use Authorizations for Medical Devices
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Regulatory science update
Modeling & simulation at FDA
Computational modeling and simulation (M&S) are powerful tools that complement traditional methods for gathering evidence about products regulated by FDA. FDA scientists routinely review results from M&S studies submitted by industry, and use M&S approaches for scientific research and regulatory decision-making. Today, FDA published a new report including case studies from across FDA, illustrating how these technologies help FDA fulfill our mission. (November 16, 2022)
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 Regulatory science funding (new opportunities)
FDA BAA
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. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023.
COVID-19 and Health Equity
FDA's Office of Minority Health and Health Equity (OMHHE) has posted a funding opportunity for COVID-19 research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making. OMHHE is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography. Letters of intent are due by December 6, 2022, and applications are due by January 16, 2023.
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Emergency Use Authorization (EUA) updates
Reminder: COVID-19 antigen tests: EUA revision for repeat testing
FDA revised the EUAs of all COVID-19 antigen tests to revise the authorized uses and require updates to product labeling regarding repeat, or serial, testing. (November 1, 2022)
COVID-19 in vitro diagnostic (test) EUAs
As of November 15, 2022, 437 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, 51 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,157 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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November 17, 2022: FDA Grand Rounds - Medical Extended Reality: Applications and Challenges (webcast, 12:00 - 1:00 p.m. ET) - FDA Physicist and CDRH Office of Science and Engineering Laboratories (OSEL) Medical Extended Reality (MXR) Program Coordinator Ryan Beams, Ph.D., will present an overview of augmented and virtual reality technology and of the landscape of potential medical applications. He will also discuss regulatory science efforts to address evaluation challenges for using augmented and virtual reality in medicine.
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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: Register now 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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New! 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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Information for industry and health care providers
ICYMI: Kineret (anakinra) injection EUA
On November 8, 2022, FDA authorized (PDF) Kineret (anakinra) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). For more information, see the fact sheets (PDFs) for health care providers and patients and caregivers. New: Frequently Asked Questions (PDF) are now also available.
FDA updates cybersecurity playbook for health care organizations
FDA collaborated with MITRE to update the Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, a resource to help health care delivery organizations prepare for cybersecurity incidents. The playbook focuses on preparedness and response for medical device cybersecurity issues that impact the functionality of a medical device. (November 15, 2022)
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
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 350 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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