Chapter 14Pharmaceuticals课件.ppt

Milestones in FDA History (1962 – 1994) Other Acts and amendments to FDC Act Fair Packaging Labeling Act – 1966 Regulation of Biologics transferred to FDA – 1972 Medical Device Amendments – 1976 Vitamins Mineral Amendments – 1976 Tamper-resistant Packaging Regulations – 1982 Orphan Drug Act – 1983 Waxman – Hatch Act – 1984 Clinical Laboratories Improvements Amendments (CLIA) – 1988 Prescription Drug User Fee Act (PDUFA) – 1992 Dietary Supplement Health Education Act (DSHEA) – 1994 精品文档 Milestones in FDA History (1992) 1992: Generic Drug Enforcement Act imposes disbarment and other penalties for illegal acts involving approval of new drug applications (NDA). Why? 精品文档 Milestones in FDA History (1992) Result of the Court’s ruling in the case of USA vs. Barr Laboratories 精品文档 Milestones in FDA History (1997) 1997: Food and Drug Administration Modernization Act (FDAMA) – Reauthorizes the Prescription Drug User Fee Act (PDUFA) of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods. 精品文档 Milestones in FDA History Increased regulation has advanced in quantum leaps because of abuses, catastrophes and the winds of political change. 精品文档 Current Good Manufacturing Practices 精品文档 What are cGMPs Good Manufacturing Practices (GMPs) are regulations that describe the methods, equipment, facilities and controls required for producing Human and veterinary products (21 CFR 210-211, 610) Medical devices (21 CFR 820) to assure that the product meets the specifications that the product is represented to possess. 精品文档 Why the “c” in cGMP? The U.S. regulations are called “current” Good Manufacturing regulations, to emphasize that the expectations are dynamic. 精品文档 Why do the GMPs exist? GMPs define a quality system that manufacturers use as they build quality INTO their products.