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Office of Women's Health

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. - Associate Commissioner for Women’s Health


U.S. Food and Drug Administration
Office of Women's Health
10903 New Hampshire Ave WO32-2333
Silver Spring, MD 20993


(301) 796-9440 Phone
(301) 847-8604 fax

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Top Tasks

Women's Health Research

We promote and conduct research initiatives that facilitate FDA regulatory decision-making, and advance the understanding of sex differences and health conditions unique to women.

Collaborate and Connect

Scientific engagement. Funding for research and educational projects. A network of over 100,000 individuals and organizations. A unique liaison between external entities and FDA. Learn how to contact and work with us.

Take Time to Care Program

Providing busy women with reliable, easy-to-read health information through outreach and collaborative partnerships with national women's health organizations, health professionals, community and faith-based institutions, industry, universities, and other government agencies.

Women's Health Topics

Women often spend so much time helping others that they don't take time for themselves. It's OK to take time to focus on good health. Watch a video or read a fact sheet to learn helpful tips.

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