Oncology Regulatory Affairs
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