Director:
Robert Justice, M.D.
Deputy Director: (Vacant)
Co-Chiefs, Project Management Staff: Frank
Cross and Dorothy Pease
The Division of
Drug Oncology Products (DDOP) regulates
Investigational New Drug Applications (INDs)
and New Drug Applications (NDAs) for small
molecule agents for the treatment and
prevention of cancer, as well as treatment of
cancer symptoms. These include
- traditional
cytotoxic compounds
- small
molecule targeted inhibitors of neoplastic
pathways
- small
molecule immunomodulators
- anti-sense
compounds
- small
molecules conjugated to antibodies
DDOP also
reviews INDs and NDAs for small molecule
agents intended to treat or prevent
hematological complications from exposure to
ionizing radiation.
Products regulated by DDOP
Mailing
Address:
Food and Drug
Administration
Center for Drug
Evaluation and Research
Division of Drug
Oncology Products
5901-B Ammendale
Road
Beltsville, MD
20705-1266
Phone:
(301) 796-2330
Fax: (301) 796-9845
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Office of Oncology Drug
Products
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