About me
Dr. Thanh Hai is the Director of the Office of New Drugs in the Center for Drug Evaluation and Research, overseeing the drug development programs for prescription and non-prescription drugs and therapeutic biologics. She is an internist/endocrinologist. She started her career at the FDA in 1998 as a medical officer in the Division of Metabolism and Endocrine Products (DMEP), and served as DMEP Director from 2006-2013. From 2013-2020 she held Office leadership positions overseeing DMEP and the Divisions for Pulmonary, Allergy and Critical Care Medicine and Analgesia, Anesthesia, and Addiction Products. She was the rapporteur for ICH E19 and participated in several PDUFA reauthorization negotiations.
