American Society of Hematology

FDA Reorganizes Approval of Cancer Therapies

Published on: September 13, 2011

The Food and Drug Administration (FDA) announced September 12 that it is realigning the offices that review and approve all drug and biologic applications for cancer therapies.

The new structure contains four divisions: Hematology Products, Oncology Products 1, Oncology Products 2, and Hematology Oncology Toxicology.

Previously there were three sections: Hematology Products, Drug Oncology Products and Biologic Oncology Products. The reorganization takes a more disease-specific approach to reviewing therapies and also makes FDA more consistent with the organizational structure of leading cancer treatment centers, academic programs and the National Cancer Institute.

Senior officials at FDA believe changes from the reorganization will not slow down pending applications, and will better support the agency’s work to get cancer treatments to patients.

Richard Pazdur will continue to serve as the office director. Dr. Pazdur will also continue to head the agency-wide program that coordinates oncology activities within the FDA as well as with external stakeholders.

Two features of the reorganization include the creation of DOP1 and DOP2, the agency's primary review divisions for cancer solid tumor therapies, and the creation of DHOT, which will review non-clinical information.

DOP1 and DOP2 will have disease-specific therapeutic areas of responsibility regardless of whether the product is a drug or biologic. DHOT is a newly created division that will be dedicated to reviewing non clinical pharmacology and toxicology aspects of cancer therapies. DHP will continue reviewing hematology therapies, including those for benign disorders and malignancies.

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