US Food and Drug Administration office of women's health: update

The Food and Drug Administration's commitment to women's health issues began a new chapter with the establishment of the Office of Women's Health in 1994. This office has worked on the regulation of various products, on FDA policy relating to the inclusion of women of childbearing potential in early-phase drug trials, and on gender analysis of drugs. This commitment to women's health issues had its beginnings in the early 1980s. Actions taken by the agency since then include focusing on approving new drugs for diseases that specifically afflict women, taking steps to increase data on how drugs affect women, strengthening labeling information to give women a more accurate understanding of how certain drugs will affect them, and conducting public education campaigns. The Office of Women's Health will continue the agency's wide-ranging efforts from drug development and approval, to labeling, to policy formulation, to public education.