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CQ – FDA Reorganizes Approval of Cancer Therapies

CQ – FDA Reorganizes Approval of Cancer Therapies


The Food and Drug Administration is realigning the offices that review and approve all drug and biologic applications for cancer therapies

, the agency announced Monday.

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.

“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 in a statement announcing the reorganization. “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.”

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

“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 review approach to these therapies,” Pazdur said in the statement. “Reorganizing the office in this manner also aligns FDA with the organizational structure of leading cancer treatment centers, academic programs and the National Cancer Institute.”

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