Dear Friends:
I invite you to join the FDA Office of Women’s Health today, from 1:00-2:30pm, for The Great Debate: What is Enough ... Women in Clinical Trials? via webcast. This special event, taking place during National Women’s Health Week, will begin with a Keynote by FDA Commissioner Scott Gottlieb. "The Great Debate" centers on the challenges and complexity of the question “What is enough?” when determining participation of women in cardiovascular disease clinical trials.
The debate participants are two leading cardiovascular experts: Ellis F. Unger, M.D., with the FDA Center for Drug Evaluation and Research, and Rita Redberg, M.D., M.Sc., F.A.C.C., University of California at San Francisco. Expect a robust discussion centering on this complex question that has been debated among academia, federal, and non-government and consumer organizations for more than a quarter century. You don’t want to miss this!
Also, please see our recent paper published in the Journal of the American College of Cardiology, Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs, which will be highlighted during the debate.
For Webcast technical support, go to Mediasite Player Help or contact your local IT administrator/technical support. Closed captioning will be provided during the webcast.
Marsha B. Henderson
Associate Commissioner for Women's Health
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