FDA Says Device Trials Need More Women

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EXCERPT:  "The FDA has issued draft guidance aimed at enrolling more women in medical device trials and better analyzing the trial data to tease out whether the particular devices work differently in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

RELATED LINK:

FDA Draft Guidance for Industry and Food and Drug Administration Staff - Evaluation of Sex Differences in Medical Device Clinical Studies, DRAFT GUIDANCE.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.