Office of Hematology and Oncology Products (OHOP)
- Organizations within the Office
- Physician Request for a Single Patient IND for Compassionate or Emergency Use
- Oncology Program
- Publications
- Presentations
- Meetings and Workshops
- What's New (Hematology and Oncology (Cancer) Approvals & Safety Notifications)
- Positions Available
- Additional Links
Reorganization of the Office of Oncology Drugs Products (OODP) to the Office of Hematology and Oncology Products
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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 is committed to facilitating rapid development, review, and action on promising new cancer therapies. Scientists within OHOP 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. Within the Office is the Office Director, Associate Director for Regulatory Science, Associate Director for Regulatory Affairs, Associate Director for Oncology Sciences, Regulatory Project Managers within the Oncology Program (program that coordinates oncology activities within the FDA as well as with external stakeholders) and support staff. There are also three clinical divisions and one nonclinical division (responsible for reviewing animal studies) within OHOP. Following is the structure of OHOP:
OHOP is committed to facilitating rapid development, review, and action on promising new cancer therapies. Scientists within OHOP 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. Within the Office is the Office Director, Associate Director for Regulatory Science, Associate Director for Regulatory Affairs, Associate Director for Oncology Sciences, Regulatory Project Managers within the Oncology Program (program that coordinates oncology activities within the FDA as well as with external stakeholders) and support staff. There are also three clinical divisions and one nonclinical division (responsible for reviewing animal studies) within OHOP. Following is the structure of OHOP:
OHOP Structure and Division Therapeutic Areas
OHOP (Oncology Program remains in the Office)
OHOP (Oncology Program remains in the Office)
Division of Oncology Products 1 (DOP1)
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Division of Oncology Products 2 (DOP2)
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Division of Hematology Products (DHP)
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Division of Hematology Oncology Toxicology (DHOT)
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Division Director, Robert Justice, MD, MS
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Division Director, Patricia Keegan, MD
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Division Director, Ann Farrell, MD
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Division Director, John Leighton, PhD
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Breast, Gynecologic, Genitourinary, Supportive care (non-heme)
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Gastrointestinal, Lung/H & N, Neuro-oncology/Rare cancers/Pediatric Solid Tumors, Melanoma/Sarcoma
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Benign hematology, Hematologic malignancy, Hematology support, Pediatric Hematology
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Nonclinical Review Division for Hematology/Oncology products
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Richard Pazdur, M.D.
Director, Office of Hematology Oncology Products
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm091745.htm
Director, Office of Hematology Oncology Products
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm091745.htm
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