Speakers

Dr. Kimberly Witzmann is a physician, and the Deputy Director for the Office of Safety and Clinical Evaluation within the Office of Generic Drugs (CDER), at FDA. The Office of Safety and Clinical Evaluation (OSCE) addresses issues related to clinical safety, substitutability, and therapeutic equivalence throughout the generic product’s lifecycle. As the Deputy Office Director, Dr. Witzmann is responsible for concentrating on complex, long-range and emerging issues impacting the clinical evaluation of generic drug products in ANDAs; she serves as the 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 as the acting Deputy Director in the Office of Bioequivalence (OB), and before that, as the team leader for the inhalation, nasal, and generic drug-device combination products team in the Office of Research and Standards. During her time in OGD, Dr. Witzmann has focused on communications with industry regarding complex drug product development. She has spoken at national meetings discussing user interface considerations for complex generic combination products, as well as development for generic orally inhaled and nasal combination drug products; she has been co-author on several medical articles published in peer-reviewed journals that discuss the scientific and regulatory challenges and opportunities associated with complex generic product development. She has been with FDA-CDER for 17 years, having 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.