The Office of Women's Health serves as an advocate for women's health throughout the Food and Drug Administration (FDA). Through and policies, the Office supports research in gender-related issues in the regulation and use of drugs, devices, biologics, and foods; initiates outreach and disseminates health information to women; provides leadership in increasing the number of women and appropriate data analysis in all phases of clinical trials; and promotes women's health in FDA actions. This article summarizes current activities and future directions in women's health at the FDA.