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GUIDANCE DOCUMENT

Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic Guidance for Industry February 2022

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2021-D-1311
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Biologics Evaluation and Research
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 help sponsors mitigate the challenges related to the constrained supply of nonhuman primates (NHPs) available for conducting nonclinical toxicity assessments, which has arisen as a consequence of the current COVID-19 pandemic

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Submit Comments Online

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-2021-D-1311 .

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