Research and Development Program

The FDA Office of Women's Health (OWH) was established by Congressional mandate in 1994 to: 1) Protect and advance the health of women through policy, science, and outreach and 2) Advocate for the participation of women in clinical trials and for sex and subpopulation analyses.

OWH achieves its mission by supporting scientific research and collaborating with other government agencies and national organizations to sponsor scientific and consumer outreach efforts that address health issues impacting women across the lifespan. Research topics include: diabetes, auto-immune diseases, breast cancer, reproductive health, and heart disease. OWH research projects and workshops:

• Look for potential sex-based differences in the safety and efficacy of FDA regulated medical products    
• Promote a better understanding of health conditions that solely or disproportionately affect women.

• Intramural Research Program - Partners with FDA research scientists to develop projects that address gaps in current knowledge or set new directions for research on sex and gender differences and other women's health issues.  Announcements are made thru FDA Notice annually, in July.  See 2011 example. 
• Extramural Research Program - Helps FDA scientists answer regulatory research questions that require technology, expertise or resources outside the agency.
• Special Funding Initiatives – Fund projects that rapidly respond to emerging or under-studied women's health issues. OWH has used Special Funding Initiatives to fund topical workshops, conduct analytical surveys and host events.
• Information Technology - Supports initiatives to develop IT tools to help track women's participation in clinical trials and to promote data standardization that will facilitate analyses of data by sex. In addition, OWH has developed web-based tools such as the Pregnancy Exposure Registries Web Portal to educate consumers and researchers.
• OWH ORISE Fellowship – The ORISE Fellowship in the FDA  Office of Women's Health (OWH) is a paid, full-time position for those seeking research experience in  women's health . Candidates must have at least a bachelor's degree in biological sciences and some research background is preferable. Typical research projects conducted by OWH staff and past OWH ORISE fellows can be found at: http://www.fda.gov/ScienceResearch/SpecialTopics/WomensHealthResearch/ucm201358.htm
  Additional general information on ORISE Fellowship can be found at http://www.orau.gov/cdc/.

 

To learn more about women's health research, visit: www.fda.gov/womenshealthresearch

To learn more about OWH consumer outreach activities, visit: www.fda.gov/womens

 

OWH Leadership

Marsha Henderson, MCRP - Assistant Commissioner for Women's Health