SOURCE: MedPage Today
DATE: December 20, 2011
EXCERPT: "The FDA has issued draft guidance aimed at enrolling more women in medical device trials and better analyzing the trial data to tease out whether the particular devices work differently in women versus men." more
FDA Draft Guidance for Industry and Food and Drug Administration Staff - Evaluation of Sex Differences in Medical Device Clinical Studies, DRAFT GUIDANCE. [Silver Spring, MD]: December 19, 2011. Center for Devices and Radiological Health; Food and Drug Administration; U.S. Department of Health and Human Services.