Docket Number:
FDA-2020-D-1136
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

FDA is issuing this guidance to provide recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2, including addressing the impact of emerging variants, during the COVID-19 public health emergency.

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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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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-1136.