|
The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- October 18, 2022: FDA Roundup including authorization of the first over-the-counter molecular test authorized for use with saliva specimens
- October 14, 2022: FDA Roundup including an FDA Voices: FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing
- October 14, 2022: FDA is requesting nominations for consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future
- October 13, 2022: FDA's Center for Drug Evaluation and Research (CDER) issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, to gather feedback from the public to inform future policy development
- October 12, 2022: Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA
Quick links: COVID-19 updates from FDA, FDA Monkeypox Response
|
|
|
COVID-19 vaccine updates
ICYMI: Bivalent boosters now available for younger age groups
Last week, FDA amended the Emergency Use Authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.
The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.
|
COVID-19 testing updates
On October 18, 2022, FDA issued an EUA (PDF) for the first over-the-counter molecular test authorized for use with saliva specimens to Aptitude Medical Inc. for their Metrix COVID-19 Test, a single-use molecular in vitro diagnostic test for the detection of SARS-CoV-2.
This test is authorized for non-prescription at-home use with anterior nasal (nares) swab and saliva sample, self-collected from people aged 14 years or older, or adult-collected from people aged 2 years or older, including people without symptoms or other epidemiological reason to suspect COVID-19.
Negative test results from saliva samples are presumptive and negative test results from anterior nasal (nares) swab samples from asymptomatic individuals should be treated as presumptive. Negative test results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative test results should be considered in the context of a person’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with additional testing, if appropriate.
Regulatory science updates
Miniature avatars take on NASA’s biggest challenge: How 3D tissue chips will help humans thrive in deep space
FDA and other agencies are collaborating with NASA on a research project to extend the life of 3D tissue chips, which will allow longer-term studies to help scientists better understand disease models, and inform drug development and clinical trial design.
FDA remains deeply engaged in identifying and fostering strategies that can bring alternative testing methods such as microphysiological systems to FDA for integration into the review process. Collaboration with our partners in the public and private sectors has been critical to advancing our efforts in this area, particularly with respect to medical countermeasures.
Last week, NASA announced the teams of researchers working to extend the tissue chip longevity to study a wide variety of biological changes including neurotoxic stressors, radiation exposure, and acute and chronic exposures to drugs.
|
Funding opportunity: Apply to become FDA’s next CERSI partner
Regulatory science is the science of developing tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
FDA works with partners to advance regulatory science through innovative research, training, and scientific exchanges. One way we do this is through Centers of Excellence in Regulatory Science and Innovation (CERSIs), which focus on cutting-edge, collaborative regulatory science research, and encourage information sharing.
The FDA Office of Regulatory Science and Innovation (ORSI), in the Office of the Chief Scientist, is seeking applications for the CERSI program. Letters of intent are due by October 31, 2022, and applications are due by December 22, 2022.
|
|
 |
|
|
Emergency Use Authorization (EUA) updates
Reminders: COVID-19 and monkeypox tests
FDA is providing voluntary templates that test developers may use when validating a test or when submitting an EUA request. Also see: Policy for Monkeypox Tests to Address the Public Health Emergency and FAQs on Testing for Monkeypox
FDA announced updates to its COVID-19 test policy, encouraging most COVID-19 test developers to pursue a traditional premarket review pathway for their tests, rather than EUA. See: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
COVID-19 in vitro diagnostic (test) EUAs
As of October 18, 2022, 436 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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 3 EUAs for molecular OTC at-home tests. FDA has authorized 35 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1,132 revisions to test EUAs. Also see: COVID-19 Test Basics
|
|
|
Events
-
October 20, 2022: COVID-19 Evidence Accelerator: What We've Learned, Where We're Headed (webinar, 1:00 p.m. ET) - A public meeting hosted by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research, to highlight accomplishments and share learnings, including how best to leverage real-world data and improve data interoperability, to address current and future health challenges.
-
November 9, 2022: Meeting of the Pulmonary-Allergy Drugs Advisory Committee (virtual, 9:00 a.m. - 5:00 p.m. ET) - The committee will discuss the request for EUA 113, for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome.
-
November 15-16, 2022: 14th Annual Sentinel Initiative Public Workshop (virtual) - Hosted by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, participants will hear from Sentinel Initiative leadership on a range of key issues including recent studies and applications of Sentinel to protect and promote public health during the COVID-19 pandemic and monkeypox public health emergency.
-
New! 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.
-
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.
Reminder: Call for abstracts: 2023 Preparedness Summit
The Preparedness Summit, the country’s first and longest running national conference on public health preparedness, is now accepting abstracts. The theme, Recover. Renew: Reprioritizing All-Hazards Preparedness, will provide an opportunity to revisit pressing issues in preparedness and share resources, shape policies, and build skills to mitigate a variety of threats. The event will be held April 24-27, 2023 in Atlanta, GA. Submit abstracts by October 24, 2022.
|
|
Information for industry and health care providers
Expiration date extension: Pfizer-BioNTech COVID-19 Vaccine
FDA granted an extension (PDF) for the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps).
Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF) have been maintained. (October 18, 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.
|
|
In case you missed it
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!)
|
Update your antibodies
The virus that causes COVID-19 changes over time. Keep your protection against COVID-19 up to date by getting a bivalent COVID-19 vaccine booster dose. 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 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.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
