On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the Biden administration plans to end the PHE phase of the pandemic response on May 11.
Of the 72 COVID-19-related guidance documents, 22 will no longer be in effect when the PHE declaration expires, 22 will be revised to continue in effect for 180 days after the expiration, 24 will be retained with revisions after the 180 days, and four will remain in effect after the declaration expires.
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