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翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Mutual Pharmaceutical Co. v. Bartlett ： ウィキペディア英語版 Mutual Pharmaceutical Co. v. Bartlett ''Mutual Pharmaceutical Co. v. Bartlett'' is a decision by the Supreme Court of the United States, holding that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug. ==Legal Background== The Federal Food, Drug and Cosmetic Act (FDCA) requires that all drug manufactures gain approval from the Food and Drug Administration (FDA) before engaging in interstate commerce. When a new brand name drug is created, the drug must be submitted under a New-Drug Application (NDA). In the NDA is a compilation of materials that must include a full report of all clinical investigations and all relevant studies. The NDA may only be approved by the FDA if they find that the drug is safe for use and the therapeutic benefits outweigh the drug's harm. Because submitting an NDA is expensive and lengthy, the Congress set out to create an easier path for generic drugs to be issued to the public. Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Act. Under Hatch-Waxman a generic drug may be approved for use without the onerous provisions of an NDA provided the generic drug is identical to an already approved brand-name drug. Under Hatch-Waxman the generic drug manufacturer is prohibited from making any changes in the drug or from making any changes to the already approved label. New Hampshire State Law imposes a duty on drug manufactures that the drugs they produce are not unreasonably unsafe. The safety of drugs is to be judged by a combination of its chemical properties and its warning label. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Mutual Pharmaceutical Co. v. Bartlett」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.