Mary Thanh Hai, MD

Dr. Thanh Hai is currently the Deputy Director for Clinical in the Office of New Drugs Immediate Office. She works directly with the OND Director to oversee the development programs of drugs and biologics regulated by the Center of Drug and Evaluation and Research across 27 review divisions. She also oversees the Office of Drug Evaluation Science including the Drug Development Tool Qualification Programs. Dr. Thanh Hai is an internist/endocrinologist receiving her medical degree from Georgetown University. Over the past 24 years, she has held several leadership positions in FDA including Director of Division of Metabolism and Endocrinology Products from 2006-2013. She served as the rapporteur for development ICH E19 Guidelines.