Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including for breakthrough therapies, expedited reviews and safety. In the OCE, Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH.