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GUIDANCE DOCUMENT

Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization December 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2020-D-1136
Issued by:
Guidance Issuing Office
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 “Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization.”  This guidance provides recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID-19, including addressing the impact of emerging variants.  The recommendations focus on the data and information that may be used to support a request for emergency use authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  This guidance supersedes the guidance entitled “Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency” issued on February 22, 2021.

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All written comments should be identified with this document's docket number: FDA-2020-D-1136.

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