Mary
T.
Thanh Hai,
M.D.
Leadership Role
Director - Office of New Drugs
Mary Thanh Hai, M.D. serves as the Director of the Office of New Drugs (OND) in the Center for Drug Evaluation and research. OND oversees the clinical and nonclinical investigations supporting drug development programs for prescription drugs and therapeutic biologics and non-prescription drugs. OND provides advice on studies in the pre-approval and post-approval periods to ensure safety of study participants and that clinical trial results meet FDA’s rigorous statutory requirement for market approval.
Dr. Thanh Hai is an internist/endocrinologist receiving her medical degree from Georgetown University. She started her career at the FDA in 1998 as a medical officer in the Division of Metabolism and Endocrine Products (DMEP). Over the years she held several leadership positions including Director of DMEP, Office Deputy overseeing three review divisions, and joined the Office of New Drugs Immediate Office in 2020 as Deputy Director for Clinical. She has also served on several internal and external committees covering a wide range of issues, including serving as rapporteur for an ICH E19 expert work group to promote selective safety data collection in late-stage pre-market and post-marketing studies and leading the Prescription Drug User Fee Act (PDUFA) reauthorization negotiations for premarket activities.