Speakers

Dr. Kimberly Witzmann is a physician and the Deputy Director for the Office of Safety and Clinical Evaluation (OSCE) within the Office of Generic Drugs (CDER), at FDA. OSCE addresses issues related to clinical safety, substitutability, and therapeutic equivalence throughout a generic product’s lifecycle. Dr. Witzmann serves as an authority on clinical review considerations and complex combination products. She is committed to making safe and effective generic drugs available to the American public. Dr. Witzmann has been with OGD for more than 11 years, also serving in the Office of Bioequivalence (OB), and before that, in the Office of Research and Standards; she spent her first 5 years in CDER’s Office of New Drugs. Prior to joining FDA in 2009, Dr. Witzmann was an assistant Professor of pediatrics at Children’s National Medical Center in Washington, DC, where she practiced pediatric pulmonology. She has prior experience as an expert lecturer and member of medical advisory boards, and has served as a primary investigator on a number of clinical research protocols involving lung diseases.