Emergency Use Authorization for Vaccines to Prevent COVID-19

On 31 March 2022 the FDA published final guidance for industry.

FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA under section 564 of the FD&C Act (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency. This document supersedes the guidance of the same title issued in May 2021 (which superseded the guidance of the same title issued October 2020 and reissued February 2021).

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