Center for Drug Evaluation and Research (CDER)

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Center for Drug Evaluation and Research (CDER)

• Tanya Eberle
• Kamal Diar
• David Clements

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Center for Drug Evaluation and Research (CDER)

• CDERs 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)

• 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.

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Center for Drug Evaluation and Research (CDER)

• 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 (GMPs),
  to register and be subject to inspection, etc.

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Center for Drug Evaluation and Research (CDER)

• Drug GMPs are associated with the following
• 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

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Center for Drug Evaluation and Research (CDER)

• 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.

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Center for Drug Evaluation and Research (CDER)

• Organization

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Center for Drug Evaluation and Research (CDER)

• January 13. FDA approves Eloxatin (oxaliplatin
  for injection) for the initial treatment of
  advanced colon cancer based on improved survival.
  Eloxatin Label.

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Center for Drug Evaluation and Research (CDER)

• 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)

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Center for Drug Evaluation and Research (CDER)

• References (contd)
• CDER Organization Charts and Directories
  http//www.fda.gov/cder/cderorg.htm
• (accessed January 16, 2004)