FDA Clarifies Status of Guidance Issued During PHE

As the COVID-19 Public Health Emergency (PHE) approaches its expected expiration on May 11, 2023, the FDA is reviewing all guidance documents related to COVID-19 to determine which will remain in effect, which will expire, and which will be revised when the PHE expires. This notice provides lists of the expected post-PHE status of all FDA COVID-related guidance documents for stakeholder planning purposes. All FDA COVID-related guidance documents may be found on the FDA COVID-19 website.