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 closely with FDA’s centers to expand existing research projects and foster new collaborations related to advancing the science of women’s health. OWH has also worked with other government agencies, academia, women’s research organizations, and other stakeholders to foster and facilitate research projects and scientific forums. These combined efforts have helped to advance our understanding of women’s health issues. They have furthered the development of new tools and approaches for informing FDA decisions about the harm or the safety and effectiveness of FDA-regulated products that are used not only by women, but by all Americans.
The Women’s Health Research Roadmap builds on knowledge gained from previously funded research and is intended to assist OWH in coordinating future research activities with other FDA research programs and with external partners. The Roadmap outlines priority areas where new or enhanced research is needed. Although many critical women’s health issues may 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.
- Advance safety and efficacy: Advance the safety and efficacy and reduce the toxicity of FDA-regulated products used by women
- Improve clinical study design and analyses: Improve clinical study design and conduct to better identify and evaluate possible sex differences related to FDA-regulated products
- Novel modeling and simulation approaches: Evaluate and promote the adoption of novel modeling and simulation approaches that can aid in regulatory evaluation of FDA-regulated products
- Advances in biomarker science: Develop tools and methods that can help identify, evaluate, and qualify predictive or prognostic clinical and non-clinical biomarkers and surrogate endpoints
- Expand data sources and analysis: 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 toxicity or the safety and effectiveness of FDA-regulated products
- Improve health communications: Develop, evaluate, and use tools and methods to foster the creation and easy availability of clear and useful information about FDA-regulated products used by women to help women and their health care professionals make informed health-related decisions
- Emerging technologies: Support the identification of sex differences related to the use of emerging technologies