Docket Number:
FDA-2021-D-0409
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Biologics Evaluation and Research
Center for Drug 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. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide recommendations to sponsors of master protocols evaluating drugs for the treatment or prevention of COVID-19.

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

If unable to submit comments online, please mail written comments to:

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All written comments should be identified with this document's docket number: FDA-2021-D-0409.