GUIDANCE DOCUMENT

Study of Sex Differences in the Clinical Evaluation of Medical Products December 2025

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number: FDA-2024-D-4245 Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Drug Evaluation and Research

Office of the Commissioner, Office of Women’s Health

Office of the Commissioner, Office of Clinical Policy and Programs

This guidance provides recommendations for (1) increasing enrollment of female participants in clinical trials and non-interventional studies to help ensure the generalizability of results, (2) analyzing and interpreting sex-specific data, and (3) including sex-specific information in regulatory submissions of medical products. In areas where male participants may be underrepresented in clinical trials, the general principles outlined in this guidance also apply to increasing enrollment of male participants in clinical trials.

Submit Comments

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-2024-D-4245.