About FDA

Office of Hematology and Oncology Products (OHOP)

Mission

The Office of Hematology and Oncology Products (OHOP) is responsible for making safe and effective drugs for cancer and hematologic conditions available to the U.S. public. OHOP oversees development, approval, and regulation of:

  • Drug treatments for cancer
  • Therapeutic biologic treatments for cancer
  • Therapies for prevention of cancer
  • Products for treatment of nonmalignant hematologic conditions

Overview

The staff of OHOP consists of over 130 highly trained physicians, scientists and regulatory project managers with expertise in oncology, hematology, radiology, internal medicine, pharmacology/toxicology, and regulatory affairs. These professionals work with specialists in other CDER scientific disciplines such as statistics, clinical pharmacology, epidemiology, chemistry, and drug safety to independently review data on new treatments for cancer.  Review Team Responsibilities.

OHOP Structure and Division Therapeutic Areas

Division of Oncology Products 1 (DOP1)

Division of Oncology Products 2 (DOP2)

Division of Hematology Products (DHP)

Division of Hematology Oncology Toxicology (DHOT)

Division Director, Julia Beaver, MD

Division Director, Patricia Keegan, MD

Division Director, Ann Farrell, MD

Division Director, John Leighton, PhD

Breast, Gynecologic, Genitourinary, Supportive care (non-heme)

Gastrointestinal, Lung/H & N, Neuro-oncology/Rare cancers/Pediatric Solid Tumors, Melanoma/Sarcoma

Benign hematology, Hematologic malignancy, Hematology support, Pediatric Hematology

Nonclinical Review Division for Hematology/Oncology products

Further Information:


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Page Last Updated: 03/30/2018
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