The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy

J Womens Health (Larchmt). 2016 Feb 12. [Epub ahead of print]

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update.

Elahi M1, Eshera N1, Bambata N1, Barr H2, Lyn-Cook B3, Beitz J4, Rios M5, Taylor DR5, Lightfoote M2, Hanafi N2, DeJager L6, Wiesenfeld P6, Scott PE1,Fadiran EO1, Henderson MB1.

Author information

• 11 Office of Women's Health (OWH) , Food and Drug Administration, Silver Spring, Maryland.
• 22 Center for Devices and Radiological Health (CDRH) , Food and Drug Administration, Silver Spring, Maryland.
• 33 National Center for Toxicological Research (NCTR) , Food and Drug Administration, Jefferson, Arkansas.
• 44 Center for Drug Evaluation and Research (CDER) , Food and Drug Administration, Silver Spring, Maryland.
• 55 Center for Biologics Evaluation and Research (CBER) , Food and Drug Administration, Silver Spring, Maryland.
• 66 Center for Food Safety and Applied Nutrition (CFSAN) , Food and Drug Administration, Silver Spring, Maryland.

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.