Busting 5 Common Myths About the FDA and Women’s Health Dr. Marjorie Jenkins, Director of Medical Initiatives and Stakeholder Engagement, Office of Women’s Health, U.S. Food and Drug Administration As a doctor and medical school professor, I have seen firsthand that men and women experience the same health problems in different ways. Physical factors like […]
FDA, Marjorie Jenkins, Myths, Sex and Gender Medicine, Women's Health
Collection, Analysis, and Availability of Demographic Subgroup Data for FDA-Approved Medical Products August 2013 In 2012, Congress passed a law, The Food and Drug Administration Safety and Innovation Act, which recommended that medical product applications submitted for marketing approval improve their demographic subgroup data’s completeness, quality, and availability. FDA was to investigate how well demographic […]
FDA, GENDER MEDICINE, legislation, researchEnrollment and Monitoring of Women in Post-Approval Studies for Medical Devices Mandated by the Food and Drug Administration Ellen Pinnow, MS, Naomi Herz, BS, Nilsa Loyo-Berrios, PhD, and Michelle Tarver, MD, PhD Women may respond differently to medical devices due to factors such as genetics, body size, hormones, or other intrinsic sex-specific or extrinsic societal […]
FDA, medical devicesReprinted from FDA Voice By: Michelle McMurry-Heath, MD, Ph.D. , August 30, 2013 Here’s ‘HoW’ Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than men do. That is why FDA is actively trying to learn more […]
FDA, medical devices