Organizational changes have taken place within the U.S. Food and Drug Administration office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).
“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,” said Richard Pazdur, MD, who joined the FDA in 1999 and became director of the office in 2005. “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.”
The new structure of OHOP involves 4 divisions disease-specific therapeutic areas of responsibility:
- Division of Hematology Products (DHP): Benign hematology, Hematologic malignancies, Hematology support, Pediatric Hematology
- Division of Oncology Products 1 (DOP1): Breast, Gynecologic, Genitourinary, Supportive care (nonhematologic)
- Division of Oncology Products 2 (DOP2): Gastrointestinal, Lung/Head & Neck, Neuro-oncology/Rare cancers/Pediatric Solid Tumor, Melanoma/Sarcoma
- Division of Hematology Oncology Toxicology (DHOT): Nonclinical Review Division for Hematology/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,” said CDER director Janet Woodcock, MD. “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.”
Source: FDA.