ODAC Chronicles: Past, Present & Future of Oncology Committees

This installment of FDA/OCE’s Conversation on Cancer, “ODAC Chronicles—the Past, Present, and Future of Oncology Advisory Committees” will focus on the role of the Oncologic Drugs Advisory Committee (ODAC) in the FDA’s regulatory review process. Previously, all oncology marketing applications were discussed at ODAC, but this is no longer feasible given the explosion of development in oncology over the last 25 years. We will also provide insight into the considerations for member selection and what preparing for an ODAC meeting entails. The panel of past and current ODAC members and regulators aims to highlight how ODAC is an integral part of the FDA assessment. We’ll specifically outline:

• ODAC composition and planning
• Topics that are brought to ODAC
• OCE efforts to streamline ODAC
• Experiences from current and past ODAC members and chairs