Naiqi Ya, PhD

Dr. Naiqi Ya is currently the Division Director for Office of Process and Facility’s Division of Process Assessment II. He has been with the FDA since 1996, beginning his career in the Office of Generic Drugs. He worked as a Chemistry Reviewer, Team Leader, Deputy Division Director and Director for Division of Chemistry IV (acting) in OGD since 2013. Dr. Ya has presented on CMC review topics at a variety of workshops and conferences. He participated in various working groups for developing Guidance for Industry and also served as an office representative in the electronic submission and electronic review project. Prior to joining the FDA, he worked in the R&D department at Biocraft Laboratories, Inc. Dr. Ya received his B.S. degree in radiochemistry from Peking University and Ph.D. degree in bioanalytical and biophysical chemistry from New York University.