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 Pharmaceutical Quality Assessment I (OPQA I) in the Office of Pharmaceutical Quality (OPQ).
Dr. Raw was involved in the development of several important FDA initiatives, including Guidances on Pharmaceutical Solid Polymorphism and Co-crystals, Regulations on Listing of Polymorph Patents, and on matters related to Nitrosamine Impurities. He was instrumental in FDA’s approval of generic versions of complex active ingredients, including Lovenox (enoxaparin sodium) and Copaxone (glatiramer acetate). Currently, he is involved in Risk and Quality Informatics Initiatives and is a principal architect of Knowledge-Aided Assessment and Structured Application (KASA). More recently, he has been involved in informatics related to artificial intelligence.
