by Robert W. Malone MD, MS
March 13, 2023
FDA NEWS RELEASE
FDA Roundup: March 10, 2023
For Immediate Release:
March 10, 2023
- Today, the 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 the FDA is revising to temporarily continue in effect.
- This notice follows an announcement from the U.S. Department of Health and Human Services that, based on current COVID-19 trends, the Department is planning for the COVID-19 PHE declared under the PHS Act to expire on May 11, 2023.
- Since the start of the COVID-19 PHE declared under the PHS Act, the FDA has been committed to providing timely recommendations and regulatory information to support response efforts.
- During the COVID-19 PHE declared under the PHS Act, the FDA has provided important tools and flexibilities to manufacturers, health care facilities, providers, patients, and other stakeholders.
- Importantly, the ending of the PHE declared under the PHS Act will not impact the FDA’s ability to authorize devices (including tests), treatments or vaccines for emergency use. Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met.
Public Health Service Act (PHS Act) is expected to expire at the end of the day on May 11, 2023.
The FDA notice addressing the agency’s COVID-19-related guidance documents, includes those guidance documents that the FDA is continuing past the expiration date. Table 3 lists the guidances and EUAs that will, for all intents and purposes, be continuing past the May 11 expiration date. Table 3 is quite extensive, but below is an image of the section mostly related to vaccines and biologics:
Read More HERE
