1. Center for Drug Evaluation and Research (CDER) Tanya Eberle Kamal Diar David Clements

2. 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).

3. 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.

4. 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 (GMP’s), to register and be subject to inspection, etc.

5. 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

6. 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.

7. Center for Drug Evaluation and Research (CDER) Organization

8. 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.Eloxatin Label.

9. 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 http://www.fda.gov/cder/about/history/default.htm (Accessed January 13, 2004)

10. Center for Drug Evaluation and Research (CDER) References (cont’d) –CDER Organization Charts and Directories http://www.fda.gov/cder/cderorg.htm http://www.fda.gov/cder/cderorg.htm (accessed January 16, 2004)