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GUIDANCE DOCUMENT

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry November 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2020-D-1370
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “COVID-19:  Developing Drugs and Biological Products for Treatment or Prevention.”  The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19.  This guidance describes FDA’s current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations.  This guidance supersedes the guidance of the same name initially issued on May 19, 2020, and reissued on February 22, 2021.

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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:

Dockets Management
Food and Drug Administration
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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