Over the past decades, substantial progress has been made to better understand the factors affecting the toxicity or the safety, efficacy (or effectiveness), and security of FDA-regulated products used by women. Since its establishment in 1994, OWH has funded numerous research projects that have expanded our understanding of the science of women’s health and aided FDA as it makes important regulatory decisions.
The goal of this Roadmap is to continue that progress by creating a formal framework for OWH funding decisions beginning with the 2017 funding cycle. The Roadmap champions women’s health science and is intended to ensure the efficient use of FDA resources while addressing the women’s health research questions that are especially important to FDA’s regulatory decision making and communications efforts. The Roadmap is another key step confirming OWH’s critical role in ensuring that FDA continues its science-based, priority-focused approach to addressing the complex and rapidly changing regulatory challenges related to women’s health. The Roadmap’s development has already served as a catalyst for better collaboration, new and potential partnerships, internal alignment, and public transparency.
Because it is considered a living document, we intend to refine and expand the Roadmap as needed to reflect present and future women’s health regulatory questions, needs, and priorities. We believe that successful implementation of the Roadmap, including through partnerships with other governmental agencies, industry, and academia, will better position FDA to answer key regulatory questions about new technologies and fulfill its regulatory mission to protect and promote public health. The Roadmap should be especially useful to stakeholders internal and external to FDA as they seek support from OWH.
To foster transparency within and outside FDA, the Roadmap will be accessible on OWH’s Women’s Health Research website, where OWH makes a variety of information available on OWH activities, including on research projects and on funding.43
43 See FDA Women's Health Research page. Accessed October 2015.