Speakers

Dr. Fang Wu is a senior pharmacologist reviewer and scientific lead for oral Physiologicallybased Pharmacokinetic modeling in Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD) in FDA. Dr. Wu has been with FDA for more than 13 years. She is responsible for using modeling and simulations tools 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 4 years and responsible for NDA and ANDA 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.