FDA outlines post-PHE provisions for COVID-19 products

On Friday, the US Food and Drug Administration (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 US 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.