Science & Research

OWH Research and Development Program

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.

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 Resarch Outcomes

As of 2015, OWH had funded 340 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.

Summary Reports

Contact FDA

301-796-9440
Fax:301-847-8604
Food and Drug Administration Office of Women's Health

10903 New Hampshire Avenue

WO32-2333

Silver Spring, MD 20993

Page Last Updated: 04/28/2016
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