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Women's Health Research Roadmap

From the FDA Office of Women's Health (OWH)

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On this page: About the roadmap | Research priority areas | Related links 

Download the Research Roadmap (PDF, 9.20 MB)

About the Women’s Health Research Roadmap

A strategy for science and innovation to improve the health of women 

Since its inception, the FDA Office of Women’s Health (OWH) has worked to support the FDA’s public health and consumer protection mission by leading and coordinating research, policy development, and educational and communication initiatives focused on women’s health. Through the OWH Research Program we have funded over 400 intramural and extramural research projects. This research spurs innovation in scientific knowledge, resulting in the discovery of novel methodologies and technologies, and improvements in the diagnoses and treatment of health conditions that impact women. By promoting collaborative research in mission-critical areas and applying new knowledge to the FDA’s review process and regulatory decisions, OWH helps the FDA foster the advancement of research that promotes and protects the health of all people in the United States. 

The updated Women’s Health Research Roadmap reflects current and future women’s health needs, priorities, and regulatory research questions. The Roadmap outlines priority areas where new or further research is needed and will serve as a catalyst for research collaborations both internal and external to the FDA. Although many critical women’s health issues warrant further examination, future OWH-funded research should focus on areas where advancements will be directly relevant to FDA as it makes regulatory decisions. The Roadmap creates strategic direction for OWH to help maximize the impact of OWH initiatives and ultimately promote optimal health for women.  

Research priority areas

  1. Advance safety and efficacy: Advance the safety and effectiveness of FDA-regulated therapeutic and diagnostic products used by women. 
  2. Improve clinical study design and analyses: Improve clinical study design, conduct, and analysis to better identify and evaluate sex differences and gender influences related to FDA-regulated products.
  3. Advance biomarker science: Develop tools and methods that can help identify, evaluate, and qualify predictive or prognostic clinical and non-clinical biomarkers and surrogate endpoints.
  4. Expand data sources and analyses: Identify, develop, and evaluate data sources and efficient techniques for data mining, data linkage, and large data set analysis that can be used to assess the postmarket safety and effectiveness of FDA-regulated products. 
  5. Improve health communications: Develop, evaluate, and facilitate the awareness and use of tools and methods to foster the creation of easily accessible, clear, and useful information about FDA-regulated products used by women to help women and health care professionals make informed health-related decisions.
  6. Promote emerging technologies and methodologies: Support the identification of sex differences related to the use of emerging technologies and methodologies, and explore strategies to leverage emerging technologies to address women’s health conditions.
  7. Combat emerging health threats: Develop and improve strategies and capabilities to better prepare for, monitor, and respond to emerging threats to women’s health.

Related links

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