Transcript Center for Drug Evaluation and Research (CDER)

Center for Drug Evaluation and
Research (CDER)
Tanya Eberle
Kamal Diar
David Clements
Center for Drug Evaluation and
Research (CDER)
CDER’s Responsibility: to ensure the
availability of safe and effective prescription,
non-prescription, and generic drugs to the
American people.
 Definition of a “Drug” – Articles intended for
use in the diagnosis, cure, mitigation,
treatment, or prevention of disease in man
(the intended use determines whether an
article is a drug).
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Center for Drug Evaluation and
Research (CDER)
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History
– Pure Food and Drugs Act 1906
• Prohibits interstate commerce of misbranded
and adulterated foods, drinks, and drugs
http://www.fda.gov/cder/about/history/Page18.htm
– Sherley Amendment 1911
• Prohibits labeling medicines with false
therapeutic claims intended to defraud the
purchaser.
Center for Drug Evaluation and
Research (CDER)
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History Continued
– Roosevelt signs the Federal Food, Drug, and
Cosmetic Act into law in 1938
• Required new drugs to be tested for safety prior to
marketing, the results of which must be submitted to FDA
in a new drug Application (NDA). Also required adequate
labeling for safe use.
– Kefauver-Harris Drug Amendments 1962
• Started June 1960, Signed into law Oct 1962
http://www.fda.gov/cder/about/history/Page31.htm
• Required drug manufacturers to prove to FDA
effectiveness of products prior to marketing, to comply
with Good Manufacturing Practices (GMP’s), to register
and be subject to inspection, etc.
Center for Drug Evaluation and
Research (CDER)
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Drug GMPs are associated with the following:
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Organization and Personnel
Buildings and Facilities
Equipment
Control of Components and Containers
Production and Process Controls
Packaging and Labeling Controls
Holding and Distribution
Laboratory Controls
Records and Reports
Returned and Salvaged Drug Products
Center for Drug Evaluation and
Research (CDER)
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Current CDER Activities
• Oversee research, development, manufacture,
and marketing of drugs to ensure compliance
with regulations
• Reviews the evidence of safety and
effectiveness of new drugs
• Monitors the safety of drug products for
unexpected drug risks post-market
• Ensures drug labeling, package inserts,
advertisements are accurate and not
misleading.
Center for Drug Evaluation and
Research (CDER)
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Organization
Center for Drug Evaluation and
Research (CDER)
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January 13. FDA approves Eloxatin
(oxaliplatin for injection) for the initial
treatment of advanced colon cancer
based on improved survival. Eloxatin
Label.
Center for Drug Evaluation and
Research (CDER)
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References
– Regulatory Affairs Professionals Society. 2001.
Fundamentals of Regulatory Affairs. Chapter 7:
Drug Compliance
– Regulatory Affairs Professionals Society. 2001.
Basic RA Training: Regulations of Drug Products.
– Food and Drug Administration. A Brief History of
The Center for Drug Evaluation and Research.
(online) Available:
http://www.fda.gov/cder/about/history/default.htm
(Accessed January 13, 2004)
Center for Drug Evaluation and
Research (CDER)
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References (cont’d)
– CDER Organization Charts and Directories
http://www.fda.gov/cder/cderorg.htm
(accessed January 16, 2004)