FDA issues guidance on study of sex differences in the clinical Evaluation of medical products

Today, FDA is announcing the availability of a draft guidance for industry entitled “Study of Sex Differences in the Clinical Evaluation of Medical Products.” Differences in physiology between females and males can lead to differences in disease manifestation, pharmacokinetics, pharmacodynamics, and response to treatment. Analyzing sex-related differences in medical product response is an important component of assessing product safety and effectiveness and can inform what goes into product labeling. Topics addressed in this guidance include:

1) Practices to improve the recruitment, enrollment, and retention of females in clinical trials, to help ensure the generalizability of research results to intended patient populations;

2) Statistical considerations for analyzing sex differences; and

3) Reporting results based on analyses of sex differences.

Take a moment to learn more about the FDA Study of Sex Differences in the Clinical Evaluation of Medical Products – Draft Guidance for Industry. Comments on the draft guidance should be submitted under docket number FDA-2024-D-4245 within 90 days after publication in the Federal Register to Regulations.gov.