In advance of the ending of the COVID-19 public health emergency on May 11, the FDA will end some of the 72 pandemic-related guidance policies and keep some in place for an additional 180 days after the PHE ends, according to a notice in the March 13 Federal Register.
Further, the FDA said, 24 policies are expected to remain in place for the long term — with revisions that will be considered by FDA leaders during the 180-day period following the end of the PHE.
“Circumstances have changed since 2020 when FDA first began issuing guidances to support COVID-19 response efforts. For example, several COVID-19 guidances were developed to
help address supply chain disruptions. In several instances, supply chains have stabilized and the relevant COVID-19 guidances are no longer needed,” the notice said.
As such, 22 policies will no longer be in effect as of May 11. The FDA also advised that 22 additional COVID-19-related policies will be kept in place for 180 days to allow for a “wind down period” so healthcare systems can ensure an orderly transition in connection with their discontinuance on Nov. 7.
As science behind some of the FDA’s policies has advanced in the past three years, the FDA said it will focus on updating an additional 24 policies during the 180-day post-PHE time frame with plans to keep them in place long term. Included in this list of policies are “Emergency use authorization for vaccines to prevent COVID-19,” “Development and licensure of vaccines to prevent COVID-19” and “FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency.”