FDA Launches Oncology Center of Excellence for Cancer Product Reviews

The FDA formally launched its Oncology Center of Excellence to coordinate the agency’s review of drugs, biologics and devices related to cancer, and officially named Richard Pazdur as its director. The center was born out of the federal government’s national cancer moonshot effort.

Former FDA Commissioner Robert Califf said the agency is currently formalizing the center’s structure. It will be organized under the Office of Medical Products and Tobacco, alongside CDER, CBER and CDRH. Pazdur previously served as the director of CDER’s Office of Hematology and Oncology Products.

Review criteria and application requirements will not change, according to the agency. In a blog post last June after being named acting director, Pazdur said the center would emulate academia and cancer care centers, and will gather regulatory scientists and reviewers with clinical expertise in oncology.

The 21st Century Cures Act, passed last December, requires the FDA to form at least one disease-centric coordinating center before the end of 2017; according to an FDA spokesperson, the agency is currently evaluating whether the oncology center fulfills that responsibility.