Docket Number:
FDA-2020-D-1137
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic which has been caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  FDA is committed to providing timely guidance to support response efforts to this pandemic. 

FDA is issuing this guidance to assist sponsors in the clinical development and licensure of vaccines for the prevention of COVID-19.

Related Information

Developing and Manufacturing Drugs Including Biologics

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: FDA-2020-D-1137.

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