FDA updates guidance on EUAs for COVID-19 vaccines

May 26, 2021

The U.S. Food and Drug Administration (FDA) updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section that clarifies how the agency intends to prioritize review of EUA requests for the remainder of the COVID-19 public health emergency.

Specifically, the FDA said it may decide not to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency during the development of the manufacturing and clinical trial processes for the vaccine.

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