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Oncology Center of Excellence

FDA Commissioner Robert Califf, OCE Director Richard Pazdur and OCE staff gathered outside White Oak Building 22

Connect With Us!

Twitter: FDAOncology • Email: FDAOncology@fda.hhs.gov

The Oncology Center of Excellence (OCE) was authorized by the 21st Century Cures Act of 2016 and established on January 19, 2017. The Center unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies. The OCE also leads a variety of research and educational outreach projects and programs to advance the development and regulation of medical products for patients with cancer.

To learn more about the Oncology Center of Excellence, please check out our OCE Annual Reports




Featured Projects and Events

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Project Confirm

Project Confirm is an initiative of the FDA Oncology Center of Excellence to promote the transparency of outcomes related to Accelerated Approvals for oncology indications.
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Project Orbis

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.
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Project Optimus

Is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development.
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OCE Summer Scholars

The FDA OCE Summer Scholars Program is designed to introduce high school students with an interest in STEM (science, technology, engineering, or mathematics) to the cancer drug development process.


OUR MISSION: The mission of the Oncology Center of Excellence is to achieve patient-centered regulatory decision-making through innovation and collaboration.

OUR VISION: We seek to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer.

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