Tamy Kim is the Director for Regulatory Affairs and Policy in the Oncology Center of Excellence (OCE) at the FDA. She also has a dual role as the Associate Director for Regulatory Affairs within the Office of Oncologic Diseases within CDER.  Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH.  She is also responsible for providing guidance to oncology review divisions and sponsor for complex regulatory issues.  During her time with FDA Oncology, Dr. Kim helped established the OCE and formed policy and procedures for Breakthrough Therapy, Accelerated approval, Real-Time Oncology Review (RTOR), expanded access, master protocols, seamless trials designs and more.