The Oncology Center of Excellence (OCE), established on January 19, 2017 under the 21st Century Cures Act of 2016, brings together experts across the Food and Drug Administration (FDA) to accelerate the review of treatments for solid and hematologic cancers. The OCE also drives research and educational outreach to enhance the development and regulation of cancer therapies.
How the OCE Works with FDA Product Centers
Drug sponsors submit their applications to the appropriate FDA product center, which decides if the product qualifies for Expedited Review. For selected products, the OCE assembles a Medical Oncology Review and Evaluation (MORE) team, which includes a medical oncology specialist and relevant product center experts.
The MORE team:
- Conducts a unified clinical review to support the development of safe and effective cancer treatments.
- Facilitates cross-center collaboration by providing input on selected Investigational New Drug (IND) applications under expedited review.
- Establishes consistent decision-making standards for Breakthrough Therapy and Fast Track designations for oncology therapies.
The finalized clinical review is sent back to the product center, which makes the final approval decision, considering both clinical and non-clinical information.
