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We seek to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer.
The mission of the Oncology Center of Excellence is to achieve patient-centered regulatory decision-making through innovation and collaboration.
The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The Center helps expedite development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. The OCE works with centers and offices across the FDA; visit Who We Are for more information.
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- Advancing Oncology Decentralized Trials
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- OCE Real-Time Oncology Review
- Project Facilitate
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- Project Point/Counterpoint
- Project Significant
Generating Evidence for Diverse Populations in Oncology
OCE's Project Facilitate call center assists oncology healthcare providers in requesting access to investigational therapies for patients with cancer.
Project Orbis provides a framework for concurrent submission and review of oncology products among international regulators, which may allow patients with cancer to receive earlier access to products.
OCE Annual Reports
The Oncology Center of Excellence reports annually on the Center's accomplishments and organization. Download the latest OCE Annual Report.
The mission of Project Socrates is to educate the next generation of oncology leaders and the public about the role of the FDA in oncology drug development.