Today the FDA announced an expansion of existing research projects to foster new studies related to advancing the science of women's health. The announcement of the Women's Health Research Roadmap will build upon existing knowledge and also outlines priority areas where enhanced research is needed (outlined below). The Leadership Council of the WHRI has called for this important next step and we applaud the FDA for improving the medical and device pipeline for us all!


Research Priority Areas:

  1. Advance Safety and Efficacy: Advance the safety and efficacy and reduce the toxicity of FDA-regulated products used by women

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Emerging Technologies: Support the identification of sex differences related to the use of emerging technologies


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