Senior Pharmacologist
US Food and Drug Administration
Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral PBPK modeling in FDA/CDER/OGD/Office of Research and Standard/Division of Quantitative Methods and Modeling (DQMM). Dr. Wu has been with FDA since 2012. She is responsible for reviewing pre-abbreviated new drug applications (pre-ANDA) meeting packages, ANDA consults and controlled correspondences. Prior to joining DQMM, Dr. Fang Wu was a biopharmaceutics reviewer for more than four years and responsible for new drug applications (NDA) and ANDA biopharmaceutics reviews. She has been a principal and co-principal investigator for multiple FDA research projects and involved in several guidance working groups and grant review panels.
Dr. Wu obtained her Ph.D. degree in Pharmaceutical Sciences from West China School of Pharmacy, Sichuan University. She also had research experiences at French National Institute for Health and Medical Research (INSERM), University of Rochester Medical Center and State University of New York (SUNY) at Buffalo. Dr. Fang Wu have published several peer-reviewed papers in the area of drug controlled release, clinical pharmacology and pharmacokinetic modeling.