FDA Forms Oncology Center of Excellence

Source: FDA

Jan 23, 2017

The U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) with Dr. Richard Pazdur as its director. This move establishes oncology as the first disease area to have a coordinated clinical review of drugs, biologics and devices across its three medical product centers, according to an FDA statement.

The OCE has been operating informally under Pazdur who was the director of the Office of Hematology and Oncology Products (OHOP) in the FDA's Center for Drug Evaluation and Research. He will remain with OHOP as acting director

Establishment of the Oncology Center was part of former Vice President Joe Biden’s Cancer Moonshot initiative.

In an interview with Medscape Medical News in June 2016, Pazdur said that bringing various experts together from across the FDA to think about clinical development of new cancer therapies is the center’s goal.

The review criteria and application requirements for medical products, as well as the work of review staff in the centers will not change.

Read the FDA statement here