Dr. Yong is a biomedical and chemical engineer by training and serves as an Associate Director of Policy in the Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) of the U.S. Food and Drug Administration (FDA) and leads policy development at the Office-level, as well as develops, advances, and represents, Center and Agency level policy positions. Her duties include management of FDA guidance document and regulation development for OTAT and liaising with other FDA Centers and external stakeholders, particularly in the advancing fields of biomanufacturing and regenerative medicine. Dr. Yong is also engaged in both FDA and standards organization activities related to tissue engineered medical products. Prior to her current role, Dr. Yong served as a Device and Combination Products Team Leader in the Division of Cellular and Gene Therapies (DCGT) where she conducted scientific regulatory review while providing oversight of DCGT programs related to regenerative medicine applications, and combination products containing a biological product in combination with a device and/or drug. Prior to joining OTAT in October of 2014, Dr. Yong was a Lead Scientific Reviewer in the Division of Surgical Devices in FDA’s Center for Devices and Radiological Health.
