Dr. Kimberly Witzmann is a physician and team leader for the inhalation, nasal, and generic drug-device combination products team, in the Division of Therapeutic Performance (DTP), Office of Research and Standards within the Office of Generic Drugs (CDER), at FDA. She is committed to making safe and effective generic drugs available to the American public. Her focus is on communications with industry for complex drug products, including communications via the controlled correspondence and pre-ANDA meetings pathways under GDUFA II. She has been a key member of teams developing guidance documents and product-specific recommendations for FDA. She has spoken nationally at multiple meetings discussing development for generic orally inhaled and nasal combination drug products, including at the International Pharmaceutical Aerosol Consortium on Regulation and Science’s 2016 meeting, 2017 FDA-USP Workshop on Standards for Pharmaceutical Products, the American Thoracic Society’s 2016, 2017, and 2018 meetings, and Respiratory Drug Delivery 2018. She has been with FDA-CDER for more than eight years, involved in regulatory science and development of complex products, particularly orally inhaled drug products. Prior to joining FDA in 2009, Dr. Witzmann was an assistant Professor of pediatrics at Children’s National Medical Center in Washington, DC. She has prior experience working with the pharmaceutical industry as a member of medical advisory boards, and has served as a primary investigator on multiple clinical research protocols involving lung diseases. She has presented locally and nationally on premature lung disease, asthma, and sleep problems in children, and has been interviewed for local and national television. She has been co-author on several medical articles published in peer-reviewed journals, and has presented a number of abstracts at national meetings.
