Oncology Regulatory Affairs and Policy Program
Image
![OCE Oncology Regulatory Affairs](https://public4.pagefreezer.com:443/content/FDA/13-05-2024T09:03/https://www.fda.gov/files/styles/main_image_medium/public/2024_oncology_regulatory_affairs_0.jpg?itok=JnzlDGXQ)
The Oncology Regulatory Affairs and Policy Program 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 Regulatory Projects
- Advancing Oncology Decentralized Trials – Learning from COVID-19 trial datasets
- Electronic Case Report Form Initiative – COVID-19-related data elements
- OCE Assessment Aid
- OCE Real-Time Oncology Review
- Project Confirm – Promoting the transparency of accelerated approval for oncology indication
- Project Point/Counterpoint – Increasing transparency of viewpoints for the Oncologic Drugs Advisory Committee