Dr. Mehta is the Director, DNP (Division of Neuropsychiatric Pharmacology), OCP (Office of Clinical Pharmacology), in CDER (Center for Drug Evaluation and Research), FDA.  With a current staff of about 28 PhDs, his division is responsible for reviewing the clinical pharmacology aspects of the Neurological, Psychiatric, Analgesic, Anesthetic, and Addiction drug products from pre-IND (Investigational New Drug) to post-NDA (New Drug Application) stages.  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 in his current position for last 22 years over which period he has contributed significantly to the approval of hundreds of NDAs.  In addition to his review oversight, administrative, and management responsibilities, he continues to play a significant role in broad based regulatory needs. For example, he represented the agency as the FDA Lead Expert on the ICH M9 EWG for BCS (Biopharmaceutics Classification System) based biowaivers guideline that was finalized in 2021; co-chair of the CDER NTI (Narrow Therapeutic Index) WG; founding co-chair and current member of the CDER BCS Committee; member of the CDER Lifecycle Management Board; co-chair of the FDA-EUFEPS-AAPS sponsored GBHI (Global Bioequivalence Harmonization Initiative) workshop; member of the FIP BCS SIG, etc. Current regulatory research interests include potential of biomarkers as confirmatory efficacy evidence for therapeutics to treat major unmet needs like Alzheimer’s disease, ALS, etc.; therapeutic equivalence of complex modified release products; NTI designation of drug products; adult to pediatric efficacy extrapolation in various indications; possible extension of BCS based biowaivers, and the CDER MIDD (Model Informed Drug Development) initiative. He has authored numerous publications and book chapters, has led WGs for the FDA ‘Hepatic Impairment’ guidance and SUPAC MR guidance, and has been a key member for several more guidance WGs. He is a charter member of AAPS and was recognized as AAPS Fellow in 2012.