OWH releases new Women’s Health Research Roadmap

Research is critical to help FDA assess the safety, efficacy, quality, and performance of FDA-regulated products. Today, the FDA Office of Women’s Health (OWH) is releasing a new Women’s Health Research Roadmap that will further the development of new tools and approaches for informing FDA decisions about FDA-regulated products that are used not only by women, but by all Americans. The Roadmap was released earlier today during Senator Barbara A. Mikulski’s visit to FDA in recognition of her nearly 30 years of support of women’s health research.

The Women’s Health Research Roadmap outlines seven priority areas where new or enhanced research is needed. This science-based framework represents a new strategic approach, developed through cross-agency collaboration, to focus regulatory science research in areas of critical importance to women’s health. The Roadmap will serve as a catalyst for future collaborations across FDA and with partners from other government agencies, academia, industry, and women’s health organizations.

Since its inception, the FDA Office of Women’s Health has worked closely with FDA’s centers and external partners to fund and facilitate research and scientific forums to advance the science of women’s health. Over the past two decades, OWH has funded 340 research projects totaling approximately $35 million. This research has contributed to safety labeling changes for medical products, new guidance for industry on product development, data standardization for vaccine clinical data, standards for evaluation of tampons and condoms, and evidence-based support for consumer decisions about products recommended for use by pregnant women. The Roadmap will build upon this previous research and strengthen FDA’s commitment to women’s health research.

Read the Women’s Health Research Roadmap