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  1. Center for Drug Evaluation and Research | CDER

Office of Oncologic Diseases (OOD) Also referred to as: formerly OHOP


The Office of New Drugs is undergoing a reorganization. This site may be updated in the near future. Please check back often. For more information, please visit Reorganization of the Office of New Drugs with Corresponding Changes to the Office of Translational Sciences and the Office of Pharmaceutical Quality.

Mission

The Office of Oncologic Diseases (OOD) oversees development, approval, and regulation of drug and biologic treatments for cancer and hematologic malignancies.  OOD is responsible for making sure that these drugs and biologics to treat cancer are safe and effective for the U.S. public.


Overview

The staff of OOD consists of over 130 highly trained physicians, scientists and program-specific regulatory project managers with expertise in oncology, hematologic malignancies, radiology, internal medicine, pharmacology/toxicology and regulatory affairs.

Additionally, in recognition of the importance of cancer therapeutic development and integration, the Oncology Center of Excellence (OCE) was established in response to the 21st Century Cures Act, which mandated that the FDA “establish one or more Intercenter Institutes within the Agency for a major disease area or areas”.  OCE is dedicated to modernizing drug, biological, and device product development and review and in creating greater efficiencies and predictability in oncology product development and review.  OOD, working in partnership with the OCE, will ensure that the Agency’s initiatives are being worked on in an efficient and cohesive manner.

OOD Structure and Division Therapeutic Areas

Office of Oncologic Diseases (OOD) Immediate Office

Office Director (Acting), Richard Pazdur, MD

Division of Oncology 1 (DO1)

Division of Oncology 2 (DO2)

Division of Oncology 3 (DO3)

Division of Hematologic Malignancies 1 (DHM1)

Division of Hematologic Malignancies 2 (DHM2)

Division of Hematology Oncology Toxicology (DHOT)

Division Director, Julia Beaver, MD

Division Director (Acting), Harpreet Singh, MD

Division Director (Acting), Steven Lemery, MD

Division Director (Acting), Angelo DeClaro, MD

Division Director (Acting), Nicole Gormley, MD

Division Director, John Leighton, PhD

Breast, Gynecologic & Genitourinary cancers, cancer supportive care

Thoracic Head & neck, Neuro-oncology Rare cancers, Pediatric solid tumors

Gastrointestinal, Superficial cutaneous cancers, melanoma, sarcoma

Acute Leukemia and Myelodysplasia, Chronic Myeloid Leukemia and others

(see text for list)

Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma, and other plasma cell malignancies

Nonclinical Review Division for Oncology products

Further Information: