Andre Raw received his B.S. degree from the Massachusetts Institute of Technology and his Ph.D. in chemistry from the University of California at Berkeley. Within his tenure at FDA he has been promoted to FDA Agency Expert and to Chemistry Division Director. Currently, he is Associate Director for Science and Communication in the Office of Life Cycle Drug Products (OLDP) in the Office of Pharmaceutical Quality (OPQ).
Dr. Raw was involved in the development of several important FDA initiatives, including the Guidance on Pharmaceutical Solid Polymorphism and Co-crystals, Regulations on Listing of Polymorph Patents, Question Based Review, and QbD Example for Generic Modified Release Products. He was instrumental in FDA’s approval of generic versions of complex active ingredients, including Lovenox (enoxaparin sodium) and Copaxone (glatiramer acetate). He is currently involved in Risk and Quality Informatics Initiatives and is a principal architect of Knowledge-Aided Assessment and Structured Application (KASA). More recently, Dr. Raw has been active in the area of Nitrosamine Impurities.
