Scientific Publications by FDA Staff

J Womens Health 2016 Mar;25(3):222-34

The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy: an update.

Elahi M, Eshera N, Bambata N, Barr H, Lyn-Cook B, Beitz J, Rios M, Taylor DR, Lightfoote M, Hanafi N, DeJager L, Wiesenfeld P, Scott PE, Fadiran EO, Henderson MB

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.