Division of Cardiometabolic and Endocrine Pharmacology, Office of Clinical Pharmacology, U.S. Food and Drug Administration
Chongwoo Yu, PhD is a Master Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology at the US Food and Drug Administration (FDA). Dr. Yu received his BS in Chemistry and MS in Physical Organic Chemistry from Hanyang University (Korea) and Dr. Yu earned his PhD in Analytical Chemistry with the focus on Drug Metabolism and Mass Spectrometry from the University of Illinois Chicago (Chicago, IL).
Subsequently, Dr. Yu has worked in the Department of Pharmacokinetics, Dynamics, and Metabolism (PDM) at Pfizer (Ann Arbor, MI) and the Drug Metabolism and Pharmacokinetics (DMPK) Department at Schering-Plough (currently, Merck; Kenilworth, NJ) for several years. At both organizations, Dr. Yu has been heavily involved in carrying out various types of drug metabolism, pharmacokinetic, and drug-drug interaction (DDI) studies using mass spectrometry.
Dr. Yu joined the FDA as a Clinical Pharmacology reviewer in 2007. Dr. Yu’s work has been focused on the evaluation of: (1) Reproductive, and Urologic Drug Products; (2) Bone and General Endocrine Drug Products; (3) Diabetes, Lipid Disorders, and Obesity Drug Products; and (4) Cardiology and Nephrology Drug Products. Dr. Yu served as a member of various FDA guidance working groups including those for: (1) Clinical Drug Interaction Studies With Combined Oral Contraceptives and (2) Bioanalytical Method Validation Guidance.