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Therapeutic Biological Products
On October 1, 2003, FDA transferred certain product oversight
responsibilities from the Center for Biologics Evaluation and
Research (CBER) to the Center for Drug Evaluation and Research
(CDER). This consolidation provides greater opportunities to further
develop and coordinate scientific and regulatory activities between
CBER and CDER, leading to a more efficient, effective, and
consistent review program for human drugs and biologics. FDA
believes that as more drug and biological products are developed for
a broader range of illnesses, such interaction is necessary for both
efficient and consistent agency action. Under the new structure, the
biologic products transferred to CDER will continue to be regulated
as licensed biologics.
To
see which product classes have been transferred and which will
remain at CBER, please refer to Transfer
of Therapeutic Products to the Center for Drug Evaluation and
Research.
The staff that was formerly with CBER as the Office of
Therapeutics Research and Review (OTRR) will maintain responsibility
for the therapeutic biologics through two new Offices that have been
formed in CDER. The following table lists the new CDER Offices and
Divisions established to review therapeutic biologic products.
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CDER Office of New Drugs: Office of Drug
Evaluation VI
Karen Weiss, MD, Director |
CDER Office of Pharmaceutical Science:
Office of Biotechnology Products
Keith O. Webber, Ph.D., Acting Director |
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Division of Therapeutic Biological Oncology Products (DTBOP)
Patricia Keegan, MD, director
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Division of Monoclonal Antibodies (DMA)
Steven Kozlowski, MD, acting director
Patrick Swann, Ph.D., acting deputy director |
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Division of Therapeutic Biological Internal Medicine
Products (DTBIMP)
Marc Walton, MD, director
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Division of Therapeutic Proteins (DTP)
Amy Rosenberg, MD, director
Barry W. Cherney, Ph.D, deputy director |
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Division of Review Management and Policy (DRMP)
Earl S. Dye, Ph.D., director |
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The therapeutic biological products now under CDER's review
include:
- Monoclonal antibodies for in-vivo use
- Cytokines, growth factors, enzymes, immunomodulators; and
thrombolytics
- Proteins intended for therapeutic use that are extracted
from animals or microorganisms, including recombinant versions
of these products (except clotting factors)
- Other non-vaccine therapeutic immunotherapies
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Date created: October 1, 2003, Date updated: September 27, 2004 |
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(9/24/2004)