FDA: Study of Sex Differences in the Clinical Evaluation of Medical Products

Tier 1: Established: peer-reviewed research or government health authority
Publisher: U.S. Food and Drug Administration (FDA), Office of Women's Health · Published: September 18, 2026 · Accessed: September 18, 2026

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Claims this source supports

• FDA states that it requires sponsors to include a fair representation of both sexes as participants in clinical trials so that clinically significant sex-related differences in response can be detected (FDA guidance document).
• The FDA draft guidance 'Study of Sex Differences in the Clinical Evaluation of Medical Products' (Docket No. FDA-2024-D-4245) provides recommendations for increasing enrollment of female participants in clinical trials and non-interventional studies to help ensure the generalizability of results.
• The same guidance recommends analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products.
• The guidance notes that in areas where male participants may be underrepresented in clinical trials, the same general principles apply to increasing enrollment of male participants.
• The guidance is issued jointly by the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, and the Office of the Commissioner (Office of Women's Health and Office of Clinical Policy and Programs).