FDA Considers Gender Differences in Cardio Trials

CDRH is scheduled to release a Level 1 draft guidance document on the sex and gender differences in cardiovascular medical device trials reviewed by FDA. Medical Technology Learning Institute will host a workshop on December 9, 2008, in Silver Spring, MD, to explore the history of including women in cardio trials, as well as regulatory considerations, treatment biases, and recruitment challenges.FDA presents recommendations for the guidance document and rationales behind those reccommendations.

November 26, 2008

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FDA Considers Gender Differences in Cardio Trials

The guidance document includes items that may affect medical device companies and others involved in the design and conduct of such studies.Speakers include Kathleen Uhl, MD, Director, Office of Women's Health, FDA, as well as various experts from industry, such as speakers from Boston Scientific, Maquet Cardiovascular, Medtronic, CardioMed Device Consultants, Thoratec (invited), and Abbott Vascular.

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