COVID-19 EUA updates | Join us for a March 9 Grand Rounds on microphysiological systems and Zika research

U.S. Food and Drug Administration sent this bulletin at 02/22/2023 08:05 AM EST

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The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include:

February 21, 2023: FDA Roundup including the FDA Voices: Highlighting Major Issues Critical to FDA Across Our Diverse Agency After One Year Back, by FDA Commissioner Robert M. Califf, M.D.
February 17, 2023: FDA Roundup including publication of the FY 2022 Medical Countermeasures Initiative (MCMi) Program Update report
February 14, 2023: FDA’s Office of Pharmaceutical Quality (OPQ) issued its 2022 Annual Report (PDF), which highlights priorities to ensure that quality drugs are available to the American public. OPQ efforts in 2022 included approval of more than 600 submissions related to drugs for COVID-19.

Quick links: COVID-19 updates from FDA, FDA Mpox Response

Reminder: MCMi Program Update

Annual report on FDA's work to support medical countermeasure-related public health preparedness and response efforts

Last week, 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.

View the report

Work with us (deadline extended)

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 March 15, 2023.

Emergency Use Authorization (EUA) updates

EUA revocations and terminations

FDA revoked or terminated EUAs for these tests for the reasons noted in the letters and notices:

February 20, 2023: CDC EV-D68 (Centers for Disease Control and Prevention)
February 14, 2023: Babson Diagnostics aC19G1 (PDF) (Babson Diagnostics)
February 14, 2023: SARS-CoV-2 NGS Assay (PDF) (Twist Bioscience Corporation)

Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.

**COVID-19 in vitro diagnostic (test) EUAs**

As of February 21, 2023, 442 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 84 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 1,244 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics

Events

FDA Grand Rounds: Microphysiological Systems as Novel Disease Models and Drug Development Tools, March 9, 2023, 12:00 - 1:00 p.m. EST

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).
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.
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.
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.
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.
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.

Information for industry and health care providers

Shelf-life extension: sotrovimab

FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK’s monoclonal antibody, sotrovimab, from 24 months to 30 months. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the Letter of Authorization (PDF). The extended expiry date for each lot can be found in Table 1 here. (February 15, 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.

In case you missed it

COVID-19 at-home tests
Check the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended. Bookmark our guide: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, and report your positive or negative test results at MakeMyTestCount.org.

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: COVID-19 Public Health Emergency Transition Roadmap.

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.

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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