FDA Office of Women's Health
This article was originally published in The Gray Sheet
Executive Summary
An upcoming Federal Register notice will announce the establishment of the Office of Women's Health within the Office of External Affairs. The office will serve as "the principal advisor to the Commissioner and other key officials on scientific, ethical and policy issues relating to women's health," a statement of organization says. The office also will monitor "the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials and the completion of gender analysis." FDA's device center is developing a report on women in device studies