March 15, 2023
FDA Guidance on PHE Ending
The Food and Drug Administration (FDA) published notice in the Federal Register on March 13, with updates to guidance documents issued during the public health emergency (PHE). Specifically, the FDA outlines which guidance documents will end with the PHE and which will be extended for a limited amount of time.
“Importantly, the ending of the PHE … will not impact 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,” the FDA stated.
Read more here.