Description
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.
Please feel free to send comments or questions
to
http://www.fda.gov/cder/comment.htm.
Richard Pazdur, M.D.
Director, Office of Oncology Drug Products
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