This Week at FDA: FDA draws roadmap for pandemic era guidances

In a Federal Register notice on Friday, FDA laid out its plans to sunset, phase out, or transition the 72 guidances it issued under the PHE declaration, which is set to expire on 11 May 2023. The guidances span all of FDA’s product centers, except for the Center for Tobacco Products, and cover topics including the agency’s watershed guidances on the development and licensure of COVID-19 vaccines, its expectations for emergency use authorization (EUA) submissions for said vaccines and guidance on remote interactive evaluations during the PHE.

The notice contains four tables that list guidances that will be transitioned in different ways: Table 1 contains guidances that will be terminated when the PHE expires; Table 2 lists 22 guidances that FDA will revise to remain in effect for 180 days after the PHE ends; Table 3 includes 24 guidances that will remain in effect for 180 days after the PHE ends that FDA plans to further revise and potentially extend further; and Table 4 comprises the four guidances that will remain in effect indefinitely.

Source: https://www.raps.org/news-and-articles/news-articles/2023/3/this-week-at-fda-fda-draws-roadmap-for-pandemic-er