Director for Regulatory Affairs and Policy, Oncology Center of Excellence (OCE) and Supervisory Associate Director for Regulatory Affairs (Acting), Office of Oncologic Diseases (OOD)
US Food and Drug Administration
Tamy Kim is the Director for Regulatory Affairs and Policy in the Oncology Center of Excellence (OCE) and Supervisory Associate Director for Regulatory Affairs Office in the Office of Oncologic Diseases (OOD) within CDER. 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, including Real-time Oncology Review (RTOR), OCE’s Medical Oncology Review Evaluation (MORE) Processes, Project Facilitate Program, Project Orbis, etc. In OOD, her responsibilities include developing policies related to review processes, including for breakthrough therapies, expedited reviews and safety. Her overarching responsibilities include problem-solving complex regulatory questions posed by the review divisions, outside stakeholders and the regulatory industry.
Disclosure information not submitted.
Tuesday, September 13, 2022
9:45 AM – 11:00 AM MST