FDA reorganizes cancer division

New structure to create "greater efficiencies"

SILVER SPRING, Md. — The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

The FDA said it would rename the Office of Oncology Products the Office of Hematology and Oncology Products. The office, which is responsible for reviewing regulatory applications for pharmaceutical and biotech drugs for cancer, is overseen by the Center for Drug Evaluation and Research. Office of Oncology Products director Richard Pazdur will continue as director of the OHOP.

"Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market," CDER director Janet Woodcock said. "We don't expect these changes to slow down pending applications; in fact, we expect to see greater efficiencies that will better support our work to get cancer treatments to patients."

The previous structure had three divisions: the Division of Hematology Products, the Division of Drug Oncology Products and the Division of Biologic Oncology Products. The new structure retains the Division of Hematology Products while creating a new Division of Hematology Oncology Toxicology and renaming the cancer drug divisions as Division of Oncology Products 1 and Division of Oncology Products 2.

"As the practice of oncology and the treatments being developed for these diseases have become more complex, we've recognized the need and importance of taking a more disease-specific approach to these therapies," Pazdur said. "Reorganizing the office in this manner also aligns [the] FDA with the organizational structure of leading cancer treatment centers, academic programs and the National Cancer Institute."

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