On October 3, the FDA’s Office of Women’s Health (OWH) unveiled its updated Women’s Health Research Roadmap. This roadmap provides a science-based framework that aims to address critical research questions pertaining to women’s health and integrates these priorities into the FDA’s research activities. One of its key functions is identifying areas where new or further research is necessary. It also fosters internal and external research collaborations that can help drive progress in this field.
Related: Women’s Health Resource Package
The OWH will utilize the updated roadmap to promote strategic research investments, enhance the scope of women’s health research, and maximize the impact of ongoing and future studies. By focusing on the unique health needs of women, the roadmap ensures that the FDA’s regulatory decisions are informed by relevant, evidence-based findings.
The updated roadmap reflects the evolving health priorities of women, emphasizing research areas that are critical for FDA’s regulatory mission.
Areas of women’s health research
Research priority areas include:
- Enhance product safety and effectiveness: Improve the safety and efficacy of FDA-regulated therapeutic and diagnostic products specifically used by women.
- Refine clinical studies: Optimize the design, execution, and analysis of clinical studies. Better understand and evaluate sex and gender-related differences in FDA-regulated products.
- Advance biomarker research: Develop tools and methods to identify, assess, and validate predictive or prognostic biomarkers and surrogate endpoints in both clinical and non-clinical settings.
- Expand data analytics: Develop and evaluate new data sources and advanced techniques for data mining, linkage, and large-scale analysis. These assess the post-market safety and effectiveness of FDA-regulated products.
- Enhance health communications: Create and promote the use of tools and strategies that make information about FDA-regulated products more accessible, clear, and helpful for women and healthcare professionals. These empower informed health decisions.
- Leverage emerging technologies: Support the identification of sex differences in the use of new technologies and methods. Explore how these innovations can address women’s health issues.
- Address emerging health threats: Strengthen strategies and capabilities to anticipate, monitor, and respond to new and evolving threats.
OWH’s future funding will concentrate on research projects directly related to FDA’s decision-making process. This ensures advancements in women’s health science are both timely and actionable.
