Cristi Stark, M.S. serves in the role of Associate Director for the Office of Science (OS) within the Center for Tobacco Products (CTP), at the Food and Drug Administration (FDA). In this capacity, she focuses on application review management as well as leading high-priority cross-cutting regulatory and policy efforts. Ms. Stark has over two decades of regulatory experience at FDA and has been with CTP since 2009. Within her time at CTP, Ms. Stark has assisted with the establishment of TPSAC, served as the first Designated Federal Officer (DFO) for Tobacco Products Scientific Advisory Committee (TPSAC), assisted with development and implementation of all premarket (PMTA, SE, EX REQ) and modified risk pathways, aided in establishment and reporting of performance metrics, served as a regulatory health project manager, Associate Director for Science Policy in OS, and more recently as the Director for the Division of Regulatory Project Management in OS. Prior to CTP she worked in two other FDA Centers, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). Prior to FDA, she worked as a biologist for the National Cancer Institute. Ms. Stark received her B.S. from the University of Maryland at College Park, and her M.S. from Johns Hopkins University.
