29 June 2016 - The FDA is honored to be an integral part of the Vice President’s National Cancer Moonshot Initiative (“Cancer Moonshot”), which calls on the agency to leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices to create the Oncology Center of Excellence.

The Oncology Center of Excellence (OCE) will expedite the development of novel combination products and support an integrated approach to tackle this devastating disease that touches so many American families.

Establishing a Center of Excellence in a disease as complex as cancer requires a thoughtful approach and we recognize that the framework of the OCE will evolve. At the same time, we remain committed to the sense of urgency that is central to the Cancer Moonshot. That is why we determined the best way to accelerate the formation of the OCE without disrupting the ongoing work within the FDA’s centers would be to appoint an internal leader in an acting capacity who can focus on bringing together oncologists across the FDA.

After a competitive internal search, I can think of no one more qualified to shepherd the agency into a new era of regulation over oncology products than the FDA’s own Dr. Richard Pazdur, who has led the FDA for nearly 20 years in reshaping and modernizing the review of cancer treatments.

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