The FDA Office of Women's Health (OWH) promotes and conducts research initiatives that facilitate FDA regulatory decision-making and advance the understanding of sex differences and health conditions unique to women.

Women's Health Research Highlights

• Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs - An examination of women’s participation and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the FDA supporting marketing applications.
• Conference Report - Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender - During this scientific conference, FDA’s Office of Women’s Health (OWH), Center for Drug Evaluation and Research (CDER) and Center for Tobacco Products (CTP) brought together thought leaders and researchers from federal and academic institutions to focus on the influences of sex and gender on nicotine and opioid use disorders.
• OWH-Funded Research Projects - The FDA Office of Women’s Health (OWH) awards research grants for 1-2 year studies to address regulatory research questions related to women's health issues and the impact of sex differences on product safety and efficacy.
  • by Funding Year
  • by Topic Area
• Research on Women and Heart Disease - OWH supports research to provide valuable insight into sex differences in the diagnosis and treatment of cardiovascular disease.
• Pregnancy Exposure Registries - Studies that collect health information from women who take prescription medicines or vaccines when they are pregnant. 
• White Paper: Successful Strategies for Engaging Women and Minorities in Clinical Trials

Research Tools and Resources

• Women's Health Research Roadmap - A strategy for science and innovation to improve the health of women.
• Research Impact and Outcomes Framework - A guide to developing an organizational impact and outcomes measurement tool for program assessment and reporting.
• FDASIA Section 907 Report: Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products
• FDASIA Section 907 Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data

Other FDA Research and Safety Monitoring Programs

• Critical Path Initiative
• FDA's Sentinel Initiative