About FDA

Description: The Research Roadmap will outline the future strategic direction for OWH’s research program, maximize the impact of OWH research funding, and better coordinate women’s health research across the Agency. The Research Roadmap will be developed based on research priority areas and questions obtained from FDA Centers and Offices as well as emerging issues and concerns identified from external medical and scientific stakeholders. The Roadmap will follow a five year plan, with the flexibility to adjust to emerging issues. It is intended to assist FDA in addressing regulatory research questions.

Accomplishment: The Women’s Health Research Roadmap represents a new strategic approach, developed through cross-agency collaboration, to focus regulatory science research in areas of critical importance to women’s health. It will form the basis for joint projects across the Agency, the Department, and with external sources to better align research priorities and leverage limited resources. Further, it will better integrate the science of women’s health into all of FDA’s research activities and will build on the OWH-sponsored portfolio of over 300 peer-reviewed journal articles. Seven priority areas have been identified where new or enhanced research is needed to assist the FDA in addressing regulatory questions in women’s health and include: 1) Advance Safety and Efficacy; 2) Expand Data Sources and Analysis; 3) Improve Clinical Study Design and Analyses; 4) Improve Health Communications; 5) Novel Modeling and Simulation Approaches; 6) Emerging Technologies; and 7) Advances in Biomarker Science. This research roadmap is important because this regulatory research will help assess the toxicity, safety, efficacy (or effectiveness), quality, and performance of FDA-regulated products. It will lead to the development and promotion of better methodologies for identifying and evaluating clinically meaningful sex and gender differences which are essential to frame good product decisions. Lastly, closing gaps in knowledge are essential to the evolving science of precision medicine in the 21st Century. More information about the roadmap is available here.