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# Sex Differences in Clinical Evaluations of Products
- URL: https://www.fdaweb.com/sex-differences-in-clinical-evaluations-of-products/
- Published: 2025-01-07T12:00:00.000Z
- Updated: 2026-09-14T14:50:14.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5158442

FDA has published a draft guidance, *Study of Sex Differences in the Clinical Evaluation of Medical Products*, with recommendations for increasing the number of females in clinical trials and non-interventional studies to help ensure the generalizability of results. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-sex-differences-clinical-evaluation-medical-products?utm%5Fmedium=email&utm%5Fsource=govdelivery) says it also has recommendations for analyzing and interpreting sex-specific data and including sex-specific information in regulatory submissions of medical products.

Historically, the agency notes, fewer females than males have been included in clinical trials of medical products, which has led to a lack of information available for females and their healthcare providers about the benefits and risks of such medical products in females.

When finalized, the guidance will replace a 7/1991 guidance.

The document contains an Introduction, Background, Clinical Trial Design and Conduct, Statistical Concepts, Nonclinical Considerations, Other General Considerations, and References.