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HHS Ends COVID-19 Emergency Use Authorizations, Shifting to Standard Regulation

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Source: HHS.gov
HHS Ends COVID-19 Emergency Use Authorizations, Shifting to Standard Regulation
Photo: HHS.gov
TL;DR Summary

HHS Secretary Robert F. Kennedy Jr. signed terminations ending the COVID-19 EUA declarations for drugs/biological products and for medical devices, with the terminations taking effect after advance notice (12 months for drugs; 180 days for devices). With traditional FDA pathways now widely available, reliance on EUA products will wind down, and regulators will aid manufacturers in pursuing standard approvals; notices will be published in the Federal Register and sent to Congress.

Topics:business#covid-19#emergency-use-authorization#fda#hhs#kennedy#policy
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  1. HHS Secretary Kennedy Signs COVID-19 Emergency Use Authorization Declaration Terminations  HHS.gov
  2. HHS to end emergency authorization for COVID-19 drugs, medical devices  American Hospital Association

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