Carolyn Cohran, PhD FDA

Carolyn Cohran, Ph. D., serves as a Policy Lead in the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) at the FDA.  The Office of Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and communicating science and risk-based policies related to drug product quality.  Carolyn has led development of MAPPs and guidances and provided guidance to industry in the area of generic drug development.  Prior to joining OPPQ, Carolyn was a Quality Assessment Lead in the Division of Lifecycle API in the Office of New Drug Products (ONDP) in OPQ.  She has spent more than twelve years with the FDA.  Carolyn received her B.S. in Chemistry from Tougaloo College in Jackson, Mississippi, and her M.A. and Ph.D. in Chemistry from Washington University in St. Louis.