FDA Announces Oncology Center of Excellence

March 02, 2017 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy
Alec Stone
Alec Stone MA, MPA, ONS Public Affairs Director

The U.S. Food and Drug Administration (FDA) recently announced, through the Office of Health and Constituent Affairs, that it has established the Oncology Center of Excellence (OCE) (https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/oce/default.htm). Longtime FDA official, Richard Pazdur, MD, has been named to lead the division as its first director. The OCE will make oncology “the first disease area to have a coordinated clinical review of drugs, biologics and devices across the agency’s three medical product centers,” according to the FDA.

Pazdur previously served as the director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research and will continue to serve OHOP as acting director. 

The former FDA administrator, Robert Califf said, “the FDA is taking important steps to formalize the structure and implementation of the OCE as part of its overarching effort to better address the needs of cancer patients, through reorganization within the FDA’s Office of Medical Products and Tobacco.”

This is an important step in helping to better understand the disease and a powerful commitment to focus efforts in that direction.

Essential aspects of the OCE will be focused on an approach to clinical trials. Noting that there is more work to do, Pazdur said, “the OCE will leverage the combined skills of oncologists and scientists with expertise in drugs, biologics, and devices to employ the best and most innovative approaches to bring forth safe new oncology products.”

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