Since the FDA’s inception in 1906, the Agency has worked to protect and promote the health of women. From identifying adulterated or unsafe products to approving new diagnostic technology, FDA strives to ensure that women in the U.S. have access to healthy foods and safe and effective medical products.
FDA strengthened its commitment to women in 1994 with the establishment of the Office of Women's Health (OWH). Since then, OWH has worked across FDA to advance the understanding and treatment of women's health issues and expand women's access to a wide variety of health and safety information.
Since 1994, FDA has increased its focus on approving medical treatments and diagnostic tools that help to improve the health of women. FDA has also changed regulations and provided guidance to industry on the evaluation of how medical products affect women. In addition, FDA has supported regulatory research that helps to identify and understand the mechanism of action for sex differences in the safety and effectiveness of FDA-regulated products as well as introduced new approaches for engaging and educating consumers and health professionals.
FDA's work has made a difference in improving the health of women. To view some of FDA's significant accomplishments in women's health since 1994, visit our Milestones and Key Events page.
Recognizing the need to provide busy women with reliable, easy-to-read health information, OWH has also prioritized consumer outreach since its founding, including the Take Time to Care Program, launched in 1998. OWH continues to provide women’s health information to consumers on a variety of topics.
- About OWH Research
- Gender Studies in Product Development: Historical Overview [ARCHIVED, from a 1995 workshop]