FDA Reorganizes Hematology and Oncology Office to Enable More Efficient Drug Review

November 12, 2019

The U.S. Food and Drug Administration (FDA) recently announced a reorganization and renaming of the office responsible for reviewing applications for new and existing cancer therapies.

The Center for Drug Evaluation and Research (CDER) Office of Hematology and Oncology Products (OHOP) has been renamed the Office of Oncologic Diseases (OOD). Richard Pazdur, MD, will serve as the acting director of OOD and continue his role as director of the FDA Oncology Center of Excellence (OCE).

“As the practice of oncology and the treatments for these life-threatening diseases have become more complex, we recognized the need to flatten the organization with additional but smaller review divisions to enable more efficient drug review,” Dr. Pazdur said. “Reorganizing the office in this manner will allow for greater stakeholder engagement in the various disease programs.”

OOD will include six divisions, each responsible for their own area of review:

  • Division of Oncology 1 (DO1) – breast, gynecologic, and genitourinary cancers, as well as supportive care
  • Division of Oncology 2 (DO2) – thoracic, head and neck cancers, central nervous system cancers, pediatric solid tumors, and rare cancers
  • Division of Oncology 3 (DO3) – gastrointestinal malignancies, melanoma, and other advanced skin cancers and sarcomas
  • Division of Hematologic Malignancies 1 (DHM1) – acute leukemia and myelodysplasia, chronic myeloid leukemia, and others
  • Division of Hematologic Malignancies 2 (DHM2) -- lymphoma, chronic lymphocytic leukemia, multiple myeloma, and other plasma cell malignancies
  • Division of Hematology Oncology Toxicology  (DHOT) – nonclinical review division for oncology products

In addition, FDA has announced a new, centralized Safety Team for the OOD, which will work with all review decisions to ensure consistent, review, management, and communication of safety information.

This reorganization is part of CDER’s continuing effort to modernize and streamline resources, ensure FDA’s physicians and staff can dedicate more time to drug development activities, and create a more efficient review process.

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