Danica Marinac-Dabic, MD, PhD, MMSc, FISPE
Office of Clinical Evidence and Analysis
Center for Devices and Radiological Health
U.S. Food and Drug Administration
Danica Marinac-Dabic, MD, PhD, MMSc, FISPE serves as the Associate Director of the Office of Clinical Evidence and Analysis, at the FDA, Center for Devices and Radiological Health (CDRH). Prior to this position she was the Director of the CDRH Division of Epidemiology. Under her leadership, in 2010 FDA/CDRH launched its MDEpiNet Initiative. Dr. Marinac-Dabic also led the development of the International Consortium of Orthopedic Registries Initiative; International Consortium of Cardiac Registries and International Consortium of Vascular Registries. From 2015-2018 she led the Registry Working Group at the International Medical Device Regulators Forum to develop series of essential principles for international convergence of registry-generated data for regulatory decision making. Since 2017, she leads the PCORTF- funded effort to establish Women’s Health Coordinated Registry Network for addressing clinical questions on devices, therapies, and their combinations for the treatment of uterine fibroids, pelvic floor disorders and female sterilization. She is a Fellow of the International Society of Pharmaco-epidemiology and Therapeutic Risk Management, Member of the Executive Operations Committee of the MDEpiNet, Member of the Steering Committee of Transcatheter Valve Therapies Registry, National Breast Implants Registry and Oxford-based IDEAL Collaborative, EXCITE International Collaborative and International Consortium of Breast Registry Activities. Prior to coming to FDA, she garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in academic environment.