Nancy Kirschbaum, PhD FDA

Nancy Kirschbaum, PhD has over 15 years of experience in regulatory science and currently serves as product reviewer in the Division of Hematology Research and Review, Office of Blood Research and Review, CBER/FDA. Dr. Kirschbaum has had extensive education and training in biochemistry, protein chemistry and molecular biology, receiving BA and PhD degrees in biochemistry from Temple University, Philadelphia PA and completing post-doctoral training at Sinai Samaritan Medical Center and the Blood Center of Wisconsin in Milwaukee, WI. Dr. Kirschbaum joined CBER in 1999. As a product reviewer, Dr. Kirschbaum’s regulatory responsibilities have included chairing review committees for license applications and supplements and acting as chemistry, manufacturing and controls scientific lead for industry meetings and investigational application review. Dr. Kirschbaum’s review focus at FDA has been on blood products derived from plasma, produced by recombinant DNA technology or incorporated into medical devices. In addition, Dr. Kirschbaum has had the opportunity to broaden her regulatory affairs experience as a consultant to industry.