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Director:
Patricia Keegan, M.D.
Deputy Director: vacant
Chief, Project Management Staff: Karen Jones
Secretary: Rhonda Hill
Program Specialist: Linda Livingston
The Division of
Biologic Oncology Products (DBOP) regulates
Investigational New Drug Applications (INDs)
and Biologic Licensing Applications (BLAs) for
therapeutic biologics intended for the
treatment and prevention of cancer, as well as
treatment of cancer treatment-related
symptoms. These products include:
- monoclonal
antibodies
- cytokines
- growth
factors
- recombinant
proteins
- enzymes
- biological
immunomodulators
- other
non-vaccine therapeutic immunotherapies, as
well as radiolabeled versions of these
products intended for therapeutic use
DBOP also
reviews INDs and BLAs for therapeutic
biologics intended to treat or prevent
hematological complications resulting from exposure to
ionizing radiation.
Products regulated by DBOP
Mailing
Address:
Food and Drug Administration
Center for Drug Evaluation and Research
Therapeutic Biological Products Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
Phone:
(301) 796-2320
Fax: (301) 796-9849
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Office of Oncology Drug
Products
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