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Danica Marinac-Dabic, MD, PhD, MMSc, FISPE (she/her/hers)

Associate Director,
FDA/CDRH/ Office of Clinical Evidence and Analysis , United States

Danica Marinac-Dabic, MD, PhD, MMSc serves as the Associate Director of the Office of Clinical Evidence and Analysis, at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), leading the development and application of novel infrastructure and methods for real-world evidence and advancing the interoperability of diverse data sources to study health technologies. Prior to this position, she was the Director of the CDRH Division of Epidemiology. Prior to coming to FDA, Dr. Marinac-Dabic garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in academic environment.

Under her leadership, FDA launched Medical Device Epidemiology Network (MDEpiNet) to advance national/international infrastructure and test innovative methods to study devices throughout their life cycle. She led a large international group of experts at the International Medical Device Regulators Forum (IMDRF) to develop series of essential principles for international convergence of registry-generated data. She has been spearheading the interoperable strategically Coordinated Registry Networks via ecosystem partnership in 12 clinical areas by linking registries to medical claims, EHRs and patient generated health data.

Dr. Marinac-Dabic was inducted as a Fellow of the International Society of Pharmaco-epidemiology and Therapeutic Risk Management (ISPE). She serves on the Advisory Board of the Council of Medical Specialty Societies, Executive Operations Committee of MDEpiNet, Active Surveillance Task Force of National Evaluation System for Health Technology, National Breast Implants Registry Steering Committee, Oxford-based IDEAL Collaborative, Editorial Board of BMJ-SIT Journal and holds an Adjunct Professor position at several academic institutions.

Disclosure information not submitted.

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