GUIDANCE DOCUMENT
Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization December 2023
- Docket Number:
- FDA-2020-D-1136
- Issued by:
-
Guidance Issuing OfficeCenter 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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2020-D-1136.