Center for Drug Evaluation and Research (CDER)课件.ppt

Center for Drug Evaluation and Research (CDER) Tanya Eberle Kamal Diar David Clements 精品文档 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). 精品文档 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 /cder/about/history/Page18.htm Sherley Amendment 1911 Prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser. 精品文档 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 /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. 精品文档 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 精品文档 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 o