Office of Oncologic Diseases (OOD) Also referred to as: formerly OHOP
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.
The OOD works in partnership with the Oncology Center of Excellence (OCE), 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 Structure and Division Therapeutic Areas
Office of Oncologic Diseases (OOD) Immediate Office
| 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) |
|
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 |
Lymphoma, Chronic Lymphocytic Leukemia, Multiple Myeloma, and other plasma cell malignancies |
Nonclinical Review Division for Oncology products |
*The Office of Regulatory Operations (ORO) is within Office of New Drugs but is no longer within OOD. The Division Director for ORO aligning with OOD is Melanie Pierce.