Device trial female populations should reflect disease prevalence -- FDA panel chair.
This article was originally published in The Gray Sheet
Executive Summary
MEDICAL DEVICE STUDY FEMALE POPULATIONS BASED ON DISEASE PREVALENCE is recommended by FDA Circulatory Systems Devices Panel Chair Julie Swain, MD, Debakey Heart Institute, Kenosha, Wisconsin. Speaking at a recent FDA-sponsored workshop on gender issues in clinical studies, Swain stated that in reviewing device study protocols for approval applications, FDA needs to "make sure that women are included not just in the general population receiving that device or having intervention for that disease but in particular in an appropriate number."
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