Mission

The Office of Oncology Drug Products (OODP) is responsible for making safe and effective drug and therapeutic biologic treatments for cancer available to the U.S. public. OODP oversees development, approval, and regulation of:

• Drug treatments for cancer
• Therapeutic biologic treatments for cancer
• Therapies for prevention of cancer
• Drug and biologic products used for medical imaging
• Products for treatment of nonmalignant hematologic conditions

Overview

The staff of OODP consists of 120 highly trained physicians and scientists with expertise in oncology, hematology, radiology, internal medicine, pharmacology, toxicology, and clinical pharmacology, along with support personnel. These professionals work with specialists in other CDER scientific disciplines such as statistics, epidemiology, chemistry, and molecular biology, to independently review data on new treatments for cancer.  Review Team Responsibilities.

OODP is committed to facilitating rapid development, review, and action on promising new cancer therapies. Scientists within OODP are working intensively on incorporating innovations in pharmacogenomics, bioinformatics, and clinical trial design into the drug development process. These efforts will provide the basis for accelerating introduction of new treatments for cancer into practice.

Richard Pazdur, M.D.
Director, Office of Oncology Drug Products