Oncology Regulatory Affairs in the Oncology Center of Excellence (OCE) collaborates with CDER, CBER, and CDRH to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review. The focus of Oncology Regulatory Affairs is the following:
- Develop and implement procedures that affect the regulatory review of medical oncology products across centers.
- Interact with colleagues in CDRH, CDER, and CBER to allow for a more coordinated review of products undergoing review by OCE.
- Hold internal-facing meetings that allow for OCE policy development.
- Provide a forum for oncology Regulatory Affairs to exchange ideas, streamline regulatory review processes and develop regulatory skills in resolving complex regulatory issues.
OCE Pilot Programs
- Oncology Center of Excellence Assessment Aid Pilot Project
- Oncology Center of Excellence Real-Time Oncology Review Pilot Program
- Project Facilitate