title: The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update.
abstract: The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.
authors.affiliation: 1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Merina
authors.initials: M
authors.lastname: Elahi
authors.affiliation: 1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Noha
authors.initials: N
authors.lastname: Eshera
authors.affiliation: 1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Nkosazana
authors.initials: N
authors.lastname: Bambata
authors.affiliation: 2 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Helen
authors.initials: H
authors.lastname: Barr
authors.affiliation: 3 National Center for Toxicological Research (NCTR) , Food and Drug Administration, Jefferson, Arkansas.
authors.forename: Beverly
authors.initials: B
authors.lastname: Lyn-Cook
authors.affiliation: 4 Center for Drug Evaluation and Research (CDER) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Julie
authors.initials: J
authors.lastname: Beitz
authors.affiliation: 5 Center for Biologics Evaluation and Research (CBER) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Maria
authors.initials: M
authors.lastname: Rios
authors.affiliation: 5 Center for Biologics Evaluation and Research (CBER) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Deborah R
authors.initials: DR
authors.lastname: Taylor
authors.affiliation: 2 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Marilyn
authors.initials: M
authors.lastname: Lightfoote
authors.affiliation: 2 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Nada
authors.initials: N
authors.lastname: Hanafi
authors.affiliation: 6 Center for Food Safety and Applied Nutrition (CFSAN) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Lowri
authors.initials: L
authors.lastname: DeJager
authors.affiliation: 6 Center for Food Safety and Applied Nutrition (CFSAN) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Paddy
authors.initials: P
authors.lastname: Wiesenfeld
authors.affiliation: 1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Pamela E
authors.initials: PE
authors.lastname: Scott
authors.affiliation: 1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Emmanuel O
authors.initials: EO
authors.lastname: Fadiran
authors.affiliation: 1 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Marsha B
authors.initials: MB
authors.lastname: Henderson
mesh_terms: D005260:Female; D006291:Health Policy / Q000639:trends; D006801:Humans; D011050:Policy Making; D011247:Pregnancy; D012586:Science; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health