Science & Research

Understanding Sex Differences at FDA

Research has shown that biological differences between men and women (differences due to sex chromosome or sex hormones) may contribute to variations seen in the safety and efficacy of drugs, biologics, and medical devices. FDA’s regulations and guidance acknowledge that understanding mechanisms of sex differences in medical product development is crucial for regulatory decisions and optimal treatment outcomes (see timeline and links below).

FDA’s Office of Women’s Health (OWH) also advocates for the participation of women in clinical trials, supports scientific sex differences research within and outside the FDA, and provides sex differences training and other resources for health professionals:

 

Key Reports, Actions and FDA Policies on Sex and Gender Considerations

 

Page Last Updated: 05/10/2017
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