|
The latest from FDA
COVID-19 vaccine updates
Recombinant Protein-Based COVID-19 Vaccines Workshop (virtual)
April 27, 2023, 9:00 a.m. - 1:00 p.m. ET
Join the Biomedical Advanced Research and Development Authority (BARDA) and FDA tomorrow for a workshop, which will provide: 1) a forum for product sponsors to discuss progress and technical challenges in the manufacturing when changing strain composition to currently circulating variants of SARS-CoV-2; and 2) an open forum for collaborative discussions to facilitate advancement of recombinant protein-based COVID-19 vaccines. (Agenda)
|
ICYMI: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines
FDA amended the EUAs of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States. (April 18, 2023)
|
|
Emergency Use Authorization (EUA) updates
EUA revocations
FDA revoked these EUAs for the reasons noted in the revocation letters (PDFs):
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 April 25, 2023, 445 tests and sample collection devices are authorized by FDA under EUAs. These include 299 molecular tests and sample collection devices, 83 antibody and other immune response tests, 62 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, 29 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 47 antigen tests and 7 molecular tests for serial screening programs. FDA has also authorized 1,354 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
|
|
|
Events
-
April 26, 2023: Virtual Town Hall - Test Development and Validation During the COVID-19 Public Health Emergency (12:05 - 1:00 p.m. ET) - FDA will host a virtual town hall for COVID-19 test developers to discuss the two final COVID-19 transition guidances.
-
New! April 27, 2023: Recombinant Protein-Based COVID-19 Vaccines Workshop (virtual, 9:00 a.m. - 1:00 p.m. ET)
-
May 4, 2023: Public Webinar Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – Draft Guidance (1:00 - 3:00 p.m. ET) - For patients, industry, and other interested stakeholders to discuss and answer questions about the draft guidance.
-
May 11-12, 2023: Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop (Silver Spring, MD or virtual)
-
May 18, 2023: Vaccines and Related Biological Products Advisory Committee meeting (virtual)
-
June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual)
Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.
|
|
Information for industry and health care providers
New draft guidance: Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
FDA announced availability of a draft guidance for industry, Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment. The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule. Submit comments by July 19, 2023. (April 19, 2023)
Updated recommendations: Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks - FDA Safety Communication
FDA, in response to questions about existing inventory that we have received from health care provider organizations that rely upon O&M Halyard surgical N95 respirators, and informed by testing results available to the FDA, is providing an update to our recommendations in the April 12, 2023, safety communication for one of the surgical N95 respirators. The FDA continues to evaluate all available information about the quality and performance of certain models of surgical N95 respirators, surgical masks, and pediatric face masks manufactured by O&M Halyard. We will continue to keep the public informed as new or additional information becomes available. (April 21, 2023)
In March 2023, FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. Learn more
|
|
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.
|
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 400 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
|
Did someone forward you this email? Subscribe.
(Select Emergency Preparedness and Response,
FDA Medical Countermeasures Initiative (MCMi) News)
|
|
|
|
|
