In 1994, the FDA Office of Women’s Health (OWH) established a research and development program to:
- Advance the evaluation of sex-based differences in the safety and efficacy of FDA-regulated products
- Conduct research on health conditions and diseases that solely or disproportionately affect women
- Track the participation of women and special populations in clinical studies and improve demographic subset analyses
- Advance scientific knowledge through advanced professional training and education in subpopulation analysis and women’s health
OWH Research Activities
The Office of Women’s Health Research and Development Program supports a variety of activities:
Intramural Research Grants
Competitive Grants: Peer-reviewed grants are awarded to FDA-scientists who respond to an annual call for proposals from OWH.
Special Funding Initiatives: Special projects are awarded to FDA scientists outside of the competitive process to respond to emerging and pressing women’s health issues. These funds can also be used to support workshops, surveys, and focus group testing.
- OWH supports scientific research to advance the science of women’s health in the form of grants, cooperative agreements, or contracts.
- FDA Broad Agency Announcement (BAA) is a specialized contract mechanism to solicit research proposals from industry, academia, and other government agencies.
- FDA Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between FDA and academic institutions to advance regulatory science through innovative research, training, and scientific exchanges.
FDA Research Program Collaborations
FDA product centers and offices directly support scientific research in the form of grants, cooperative agreements, or contracts. OWH collaborates with other FDA research programs, like the Critical Path Initiative,* to better integrate women’s health research questions into their research activities.
External Research Collaborations
These may involve special projects conducted with other governmental agencies and other external partners to help FDA leverage all available technologies, expertise, and resources when addressing complex research questions.
OWH Workshops and Training
Scientific workshops and trainings/curriculum development for health professionals are designed to advance the understanding of women‘s health and sex-related differences.
OWH Conducted Research
OWH projects have been launched to assess the level of participation by women and analysis of outcomes by sex in clinical trials in support of product applications submitted to FDA.
Visit the Research Initiatives page to learn more about OWH research efforts.
Read the OWH Women's Health Research Roadmap to learn more about the priority research areas.
OWH Research Outcomes
As of 2017, OWH had funded 368 research projects. Projects have ranged from investigating listeria in pregnancy and cosmetic safety to the study of, sexually transmitted infections, cardiovascular disease, breast cancer, reproductive health, endocrine and neurological disorders, and psychiatric disorders, among other conditions. This research has contributed to safety labeling changes for medical products, new guidance for industry on product development, data standardization for vaccine clinical data, standards for evaluation of tampons and condoms, and evidence-based support for consumer decision about products recommended for use by pregnant women (e.g., the risks and benefits of fish consumption). OWH-funded research has also served as the foundation for the development and expansion of other women’s health research activities, including, for example, the National Center for Toxicological Research’s annual Women’s Health Research Program.
The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update. Journal of Women's Health Vol 25. Elahi M, Eshera N, Bambata N, Barr H, Lyn-Cook B, Beitz J, Rios M, Taylor DR, Lightfoote M, Hanafi N, DeJager L, Wiesenfeld P, Scott PE, Fadiran EO, Henderson MB. (March 2016)
The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy. Journal of Women’s Health Vol 16. Obias-Manno D, Scott PE, Kaczmarczyk J, Miller M, Pinnow E, Lee-Bishop L, Jones-London M, Chapman K, Kallgren D, Uhl K. (August 2007)
Protecting and Advancing the Health of Women - A Congressional Briefing (ARCHIVED, May 2005)
Women's Health Science Program - 2001 Update to Accomplishments Report (ARCHIVED, June 2001)
Office of Women's Health Scientific Research Program Accomplishments Report (ARCHIVED July 2000)