Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
FDA, CDER, OTS
Dr. Mehta is the Director, DCP I (Division of Clinical Pharmacology I), OCP (Office of Clinical Pharmacology), in CDER (Center for Drug Evaluation and Research), FDA. His division is responsible for reviewing the clinical pharmacology and biopharmaceutical aspects of the Cardio-Renal, Neuropharmacological and Psychiatric drug products. He obtained his M.Sc. from University of Bombay in Synthetic Organic Chemistry in 1979, M.S. from University of Houston in Medicinal Chemistry in 1981, and his Ph.D. in Pharmacokinetics from the University of Pittsburgh in 1986 and joined FDA as a reviewer the same year. He has been with the Agency for last 29 years and in his current position for last 16 years.
In addition to his review oversight, administrative, and management responsibilities, he continues to play a significant role in broad based regulatory needs. For example, currently he co-chairs the CDER BCS (Biopharmaceutics Classification System) Committee, is a member of the CDER Lifecycle Management Board, is a member of the FIP BCS SIG, and is the Chair of the OCP Working Group for revising the CDER ‘PK in Hepatic Impairment’ guidance issued in 2003.
Current research interests include therapeutic equivalence of complex modified release products, disease progression modeling in Parkinson’s disease, efficacy extrapolation in pediatrics for epilepsy drugs, and possible extension of BCS based biowaivers. He has authored numerous publications, guidances and book chapters. He was recognized as AAPS Fellow in 2012.