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Oncology Center of Excellence


Dr. Richard Pazdur photo 9-15-16 ver. 2

Richard Pazdur, M.D.
Director, Oncology Center of Excellence


Spotlight

Do you need help submitting a single patient IND Expanded Access (EA)/compassionate use request for a patient with cancer? FDA’s OCE can help Locate IRB resources, find an EA contact for a drug/biotech company, and complete Form FDA 3926. 8:00 AM – 4:30 PM Eastern Time (M-F); Phone: (240) 402-0004; Email: OncProjectFacilitate@fda.hhs.gov Patients: talk to your healthcare provider to discuss whether expanded access is an appropriate option. www.fda.gov/OCE

The Oncology Center of Excellence Project Facilitate call center is a pilot program to assist oncology healthcare providers in requesting access to investigational therapies for patients with cancer.

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About the Oncology Center of Excellence

The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices (including diagnostics). This Center of Excellence will help expedite the development of oncology and hematology medical products and support an integrated approach in the clinical evaluation of drugs, biologics, and devices for the treatment of cancer. The OCE works with centers and offices across the FDA; visit Who We Are for more information.

Mission and Vision Statements

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

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

News & Events

OCE Programs

Resources

 

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