2023-05094: Guidance Documents Related to Coronavirus Disease 2019 (COVID-19)
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On February 9, 2023, the Secretary of Health and Human Services (HHS) renewed the Coronavirus Disease 2019 (COVID-19) public health emergency declaration issued under section 319 of the Public Health Service Act (PHS Act) ("PHE declaration"), effective February 11, 2023. The declaration is expected to expire at the end of the day on May 11, 2023. The Food and Drug Administration (FDA, Agency, or we) has issued guidance documents to address the circumstances of the public health emergency and, more generally, COVID-19. Many of those guidance documents are tied to the duration of the PHE declaration. This notice is intended to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidances that FDA is revising to continue in effect after the expiration of the PHE declaration.
The agency’s own summary, as published.
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