The Food and Drug Administration Office of Women’s Health (OWH) was established by Congressional mandate in 1994, as part of the Office of the FDA Commissioner.
The mission of the office is to:
- Serve as the principal advisor to the Commissioner and other key Agency officials on scientific, ethical, and policy issues relating to women's health.
- Provide leadership and policy direction for the Agency regarding issues of women's health and coordinate efforts to establish and advance a women's health agenda for the Agency.
- Promote the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials and the completion of sex/gender analysis.
- Identify and monitor the progress of crosscutting and multidisciplinary women's health initiatives including changing needs, areas that require study, and new challenges to the health of women as they relate to FDA's mission.
- Serve as the Agency's liaison with other agencies, industry, professional associations and advocacy groups with regards to the health of women.
OWH achieves its mission through the foundational principle that Sex as a Biological Variable (SABV) should be factored into research design, analysis, reporting and education. To this end, OWH supports FDA’s regulatory mission by engaging in scientific research and collaborating with stakeholders to engage in scientific and educational projects. These initiatives are coordinated through three program areas:
To learn more about FDA resources on women's health, visit: For Women
Kaveeta Vasisht, M.D., Pharm.D. - Acting Associate Commissioner for Women’s Health