You are subscribed to FDA Press Releases for U.S. Food & Drug Administration (FDA).
This information has recently been updated and is now available.
12/16/2011 09:12 AM EST
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.