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

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This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. Clinical trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. When finalized, this guidance will replace the guidance entitled “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs” issued in July 1993.