文章摘要
刘凤媛.药品侵权救济中的法律适用与政府监管——Diana Levine v. Wyeth案美国最高院判决的评析[J].南京医科大学学报,2009,29(3):217~221
药品侵权救济中的法律适用与政府监管——Diana Levine v. Wyeth案美国最高院判决的评析
Application of law and government supervision in the drug infringement remedy: comments on the case of Diana Levine v. Wyeth in supreme court of the United States
投稿时间:2009-06-10  
DOI:10.7655
中文关键词: 药品侵权救济  法律适用  政府监管  非那根
英文关键词: drug infringement remedy  application of law  government supervision  Phenergan
基金项目:
作者单位
刘凤媛 东南大学法学院,江苏 南京 210096 
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中文摘要:
      文章就非那根案例,围绕美国食品药品管理局(FDA)与州侵权法庭的法律优先适用和政府监管与侵权救济的问题展开讨论?根据FDA“有效改变规则”,该案实则不存在法律优先适用问题,但基于此的争论对《联邦药品食品化妆品法》与州侵权法,乃至药品的政府监管与侵权救济的关系的探究有着重要意义?
英文摘要:
      The Phenergan whose label had been approved by FDA caused a patient amputated. Heated debats on the preemption issues between FDA and State Tort Court, and about government supervision and drug infringement remedy were under way. According to the CBE regulation, there was no preemption issue, however, the arguement concerning that played an important role in the study on relationship not only between Federal Food, Drug & Cosmetic Act and State Tort Law, but also between government supervision and infringement remedy.
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