Food and Drug Administration Commissioner Robert M. Califf, MD, has named Richard Pazdur, MD, to serve as the acting director of the FDA’s Oncology Center of Excellence (OCE), an outgrowth of Vice President Biden’s National Cancer Moonshot Initiative.
The center will expedite the development of novel combination products and support an integrated approach to the disease, according to a written statement from the FDA.
Dr. Pazdur joined the FDA in 1999 and most recently served as the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. In his new role as acting director of the OCE, Dr. Pazdur will be responsible for leading the effort to develop and execute an integrated regulatory approach for clinical product review with coordination between centers and collaboration with stakeholders.
“Dr. Pazdur is the person the FDA needs to get the OCE up and running, because of his in-depth understanding of the inner workings of the FDA, his deep expertise in treating this complex disease, and his ability to move the agency forward in this complicated task,” Dr. Califf said.
“I am honored to be selected by Commissioner Califf today as the acting director of FDA’s new Oncology Center of Excellence in support of the Vice President’s National Cancer Moonshot Initiative,” Dr. Pazdur wrote in a separate written statement. “I look forward to guiding the agency through this initial phase, building our cross-disciplinary review staff, providing external outreach to diverse stakeholders, and streamlining administrative processes to ensure rapid review of important cancer products to the American public,” he added.
Specific details about how the center will function to accomplish its goals have not yet been released.
“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,” Dr. Califf said.
Dr. Pazdur will work with directors from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health to formalize a seamless cross-center regulatory approach. He will also be responsible for streamlining engagement and collaboration with oncology stakeholders, including patient-focused advocacy groups, professional associations, industry, academia, and sister agencies such as the National Institutes of Health.
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