July 10 -- The Food and Drug Administration (FDA) solicits input and comments from stakeholders on strategic priorities for the Office of Women's Health (OWH). These will help the FDA ensure that important health concerns are carefully considered in establishing OWH's scientific, educational, and outreach priorities. Comments are due by September 8, 2020.
FR notice:
https://www.federalregister.gov/documents/2020/07/10/2020-14878/office-of-womens-health-strategic-priorities-establishment-of-a-public-docket-request-for-comments
To maximize FDA OWH's ability to promote, protect, and advance the health of women, we are seeking input on research priorities driven by data gaps and areas of unmet need; topics for education among consumers, health professionals, and other stakeholders; and outreach to women, especially underserved and diverse populations. We are also interested in proposed methods for acting on these priorities, such as collaborations and partnerships. In particular, OWH requests comments on:
Efforts to encourage analysis and detection of potential sex and gender differences in the safety, efficacy, and use of FDA-regulated products.
Efforts to anticipate, meet, and respond to existing and emerging issues related to women's health and FDA-regulated products.
Direct outreach to diverse groups of women to promote access to relevant information about FDA-regulated products, encourage participation in clinical trials, and maintain dialogue about critical women's health topics.
Coordination and collaboration with other Federal Agencies and external stakeholders to support research and programming on women's health topics.
Identification of regulatory decisions that can benefit from participation of women across the lifespan (e.g., reproductive-age women, pregnant women, post-menopausal women, and elderly women) and women with certain health conditions.
Generation of research and programming topics, interests, and areas of focus that predominantly affect women and/or would benefit from sex- and gender-related analyses.
FDA's OWH was established by Congressional mandate in 1994 as part of the Office of the Commissioner. The mission of the OWH is to:
Provide leadership and policy direction for the Agency related to women's health and coordinate efforts to establish and advance a women's health agenda for the Agency.
Promote the inclusion of women in clinical trials, the implementation of guidelines concerning the representation of women in clinical trials, and the incorporation of sex and gender considerations into clinical trial data analysis.
Identify and monitor the progress of crosscutting and multidisciplinary women's health initiatives including changing needs, areas that require study, and new challenges to the health of women as they relate to FDA's mission.
Serve as the Agency's liaison with other agencies, industry, professional associations, and advocacy groups with regards to the health of women.
OWH achieves its mission through the foundational principle that sex as a biological variable should be factored into research design, analysis, reporting, and education. To this end, OWH supports FDA's regulatory mission by funding and engaging in intramural and extramural scientific research and collaborating with stakeholders on educational and outreach projects. More information on OWH research and educational activities is available at
https://www.fda.gov/science-research/science-and-research-special-topics/womens-health-research.
Point of contact: Lisa Lineberger, Office of Women's Health, Office of the Commissioner, FDA 301-796-8751 lisa.lineberger@fda.hhs.gov
