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  1. OWH News and Updates

Celebrating Women’s Health

From FDA Office of Women's Health

Image of ethnically diverse women smiling

FDA strives to ensure that women in the U.S. have access to healthy foods, and safe and effective medical products.  

FDA Office of Women’s Health (OWH), part of the Office of the Commissioner, was established in 1994 to protect and advance the health of women and provide leadership on women’s health topics within the agency. OWH protects and promotes the health of women through policy, science, education, and outreach. 

This women’s history month, we’re reflecting on and celebrating 30 years of working across FDA to advance the understanding and treatment of women's health conditions and to expand women's access to a wide variety of health and safety information

OWH’s mission 

OWH works across the agency to identify and monitor initiatives and emerging topics in women’s health as they relate to FDA’s regulatory mission. OWH also serves as the principal advisor to agency leadership on scientific, ethical, and policy issues relating to the health of women. OWH achieves its mission by funding research, being involved in policy development, providing professional training and education to FDA scientists and staff on the importance of considering sex differences in their work, and developing consumer educational information for women and their families.

OWH achieves its mission by focusing on the foundational principle that Sex as a Biological Variable (SABV) should be factored into research design, analysis, reporting, and education.

OWH funds research projects addressing health conditions affecting women across their lifespan, including—for example—endocrine and metabolic disorders, cardiovascular disease, breast cancer, sexually transmitted infections, and issues related to pregnancy. OWH’s Research Program has funded over 400 intramural and extramural research projects that have driven innovation and have resulted in improvements in diagnoses and treatments that protect and promote the health of women. 

OWH brings in world-renowned experts to deliver educational seminars to FDA staff on the importance of sex and gender considerations in regulatory science. We offer training opportunities, such as research fellowships within FDA Centers and advanced pharmacy practice experiences (APPE or “rotations”) for student pharmacists.

Bench to Bedside: Integrating Sex and Gender to Improve Human Health is a course consisting of self-paced webinars our office developed in partnership with National Institutes of Health (NIH) Office of Research on Women’s Health. In addition, in 2023 we began offering a public health regulatory webinar series with free continuing education credits for health professionals and students. 

OWH collaborates with other agencies, industry, professional associations, and advocacy groups to address issues that are critically important to the health of women. In addition, the office hosts public scientific workshops focused on women’s health, past topics include opioids, CBD, menopause, and leveraging real-world data to study medication use in pregnancy and lactation. 

OWH offers more than 40 fact sheets, brochures, and medicine booklets on a wide range of health topics including safe medication use, heart disease, HIV, HPV, menopause, birth control, pregnancy exposure registries, and more. We disseminate materials nationwide through outreach collaborations with a variety of stakeholders. 

OWH 30th anniversary Mark

Women’s History Month 

Women’s History Month is celebrated every year in March as a time to honor women’s contributions in American History. Throughout our 30-year history, OWH has promoted initiatives and conducted research that facilitates FDA regulatory decision-making and advances the understanding of sex differences and health conditions unique to women. Our ongoing work ensures that FDA-regulated medical products are safe and effective for women and that all women and health care professionals have equal access to important women’s health resources and tools now and in the future. 

This Women’s History Month, OWH celebrates and acknowledges women in leadership positions at FDA. Meet the FDA Associate Commissioner for Women’s Health, Kaveeta P. Vasisht, MD, Pharm.D. Learn more about OWH’s leadership over the years, and the contributions of pioneering women who made significant and long-lasting contributions to public health during their careers with the Food and Drug Administration. 

This month and beyond, take charge of your health. Use and share OWH’s women’s health resources to help you make informed decisions about your health and the health of those you care for. 

Historical Artifacts Showcase Women’s Health

FDA’s actions to protect women’s health over the years are memorialized in the FDA’s History Vault. Whether through accelerating an approval, removing a product from the market, or by issuing guidance on nutrition and dietary supplements, the FDA has used its regulatory authorities to advance women’s health. The FDA History Office has created a virtual exhibit highlighting the agency’s long-standing commitment to protecting and promoting women’s health. These historical artifacts and images can be viewed remotely on FLICKR

Learn more about OWH and our women’s health resources:

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