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GUIDANCE DOCUMENT

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry May 2020

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1370
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

[Updated 2/22/21]

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.

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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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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1370.

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