publication date: Nov. 8, 2019

FDA Office of Hematology and Oncology Products is now Office of Oncologic Diseases

By Matthew Bin Han Ong

The Office of Hematology and Oncology Products at FDA has been renamed the Office of Oncologic Diseases—a move that includes an internal reorganization of divisions, as part of modernization plans approved in September 2019.

The OOD, which is part of the Center for Drug Evaluation and Research, continues to be responsible for reviewing applications for new and existing cancer therapies, with the exception of non-malignant hematology.

“The name change reflects the emphasis on oncology and malignant hematology, with the move of non-malignant hematology to a new division in the Office of Cardiology, Hematology, Endocrinology, and Nephrology,” Richard Pazdur, acting director of OOD and director of the FDA’s Oncology Center of Excellence, said to The Cancer Letter.

Pazdur joined FDA in 1999 as director for the Division of Drug Oncology Products, and became OHOP director in 2005. The OCE is not affected by the OHOP reorganization.

“The reorganization creates a flatter structure by creating additional smaller divisions,” Pazdur said. “This will allow the division directors more time to work directly with staff to maintain and improve the high quality of application reviews.”

A conversation with Pazdur appears below.

OHOP contained three clinical divisions and one nonclinical division: Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), Division of Hematology Products (DHP), and Division of Hematology Oncology Toxicology (DHOT).

The new OOD structure consists of six divisions:

DOP1 is re-named Division of Oncology 1 (DO1).

DOP2 will be split into two divisions: Division of Oncology 2 (DO2) and Division of Oncology 3 (DO3). … Continue reading FDA Office of Hematology and Oncology Products is now Office of Oncologic Diseases

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