FDA Will Retain Some Guidances After End to COVID Emergency

The FDA has decided the postpandemic fate of 72 final guidances published over the past three years to address COVID-19 issues, choosing to withdraw about one-third, phase out another one-third and retain most of the remainder but plan to update them in the near future.

Twenty-two documents will expire on May 11, the end date set for the Public Health Emergency (PHE), the FDA said in an announcement on Friday, because their content is represented in other guidances, the conditions outlined in the guidances have changed or “stakeholders have resumed or adjusted operations and are no longer relying on the guidances.” These include directions on manufacturing processes, new drug applications and prescription drug marketing and distribution.

Another 22 documents will expire after a “wind-down period” of 180 days to give companies, healthcare providers, patients, consumers and the FDA time to transition away from the policies. These include manufacturing inspections and device guidances.

The agency identified 24 documents to be revised in the 180 days after the PHE declaration expires, including emergency use authorization for COVID-19 vaccines.