Deputy Director for Clinical Science
FDA/CDER/Office of New Drugs
Dr. Thanh Hai is currently the Deputy Director for Clinical Science in the Office of New Drugs Immediate Office, working directly with the Super Office Director overseeing 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 Biomarker and Clinical Outcome Assessments Qualification Programs, the Biomedical Informatics Team, the OND Research Program, and the Drug Trials Snapshot Program. Dr. Thanh Hai is an internist/endocrinologist receiving her medical degree from Georgetown University. She has held several leadership positions including Director of the Division of Metabolism and Endocrine Products (DMEP) from 2006-2013, Deputy Office Director for the Office of Drug Evaluation 2 from 2013-2020 overseeing three review divisions: DMEP, Division of Pulmonary, Allergy, and Rheumatology Products (DPARP), and Division of Anesthesia, Analgesia, and Addiction Products (DAAAP), and she served as the rapporteur for the development of ICH E19 Guideline - Selective Safety Data Collection in late-stage pre-approval and post-approval clinical trials which was finalized in September 2022.
Disclosure(s): No financial relationships to disclose
Fountain of Youth: Fighting Aging to Prevent Age-Related Diseases
Friday, March 29, 2024
11:00 AM – 12:00 PM MDT