Science & Research

Regulations, Guidance, and Reports related to Women’s Health

FDA has been committed to addressing women’s health since its inception in 1906, as illustrated by events in its history, such as FDA’s reversal of guidance that effectively excluded women of childbearing potential (WOCBP) from clinical studies. Guidance and other FDA regulations are ways in which FDA communicates its current thinking on issues related to FDA regulated products (evaluation, development, etc.). Several of these regulatory documents have addressed women’s health over FDA’s history and have impacted the way in which women are enrolled in clinical trials and sex analyses are conducted. 













Page Last Updated: 02/16/2018
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