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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All written comments should be identified with this document’s docket number: FDA-2020-D-1370.
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Content current as of:
12/05/2023
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