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FDA致力于通过确保药品的质量、安全和有效来保护和促进公众健康。因此,当涉及新的安全问题时,FDA有权要求对药品标识进行变更。实际上,在2007年的《食品药品管理法修正案》(FDAAA)通过之前,FDA的权利还仅限于请求标识变更。随着FDAAA的通过,FDA有权在某些情况下要求安全标识变更。FDAAA有关药品安全标识的规定被加入到了《联邦食品、药品与化妆品法案》的505(o)(4)条款中,FDA于2013年7月公布了实施该条款的行业指南。本文翻译了该指南的主要内容,以期对我们了解美国的相关政策并加以借鉴有所帮助。
The FDA is committed to protecting and promoting public health by ensuring the quality, safety and efficacy of medicines. Therefore, the FDA has the right to request a change of labeling when it comes to new safety issues. In fact, prior to the FDA Food and Drug Control Amendment Act (FDAAA) passed in 2007, the FDA’s rights were limited to requesting identification changes. With the FDAAA’s approval, the FDA reserves the right to request a change of security mark under certain circumstances. The FDAAA regulation on drug safety labeling was added to section 505 (o) (4) of the Federal Food, Drug, and Cosmetic Act, which was published in July 2013 by the FDA and is the industry guide for implementing the article. This paper translated the main content of the guide, with a view to our understanding of the United States and relevant policies to help.