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GUIDANCE DOCUMENT

Mpox: Development of Drugs and Biological Products; Guidance for Industry January 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2022-D-2395

Docket Number:
FDA-2022-D-2395
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

FDA is issuing this guidance to support sponsors in their development of drugs1 for mpox. This guidance provides nonclinical, virology, and clinical considerations for mpox drug development programs, with a focus on recommendations to support initiation of clinical trials.

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