Lexology March 16, 2023
Baker & Hostetler LLP

Key Takeaways

  • The FDA has issued a Federal Register notice explaining how the end of the COVID-19 Public Health Emergency (PHE) declaration will impact the Agency’s 72 COVID-related guidance documents.
  • Of the 72 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.
  • All FDA-regulated industries should review the categorization of FDA guidance documents related to COVID-19 and assess whether their practices are compliant with current FDA guidance.
  • Firms continuing to operate under FDA guidance that is no longer in effect...

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