FDA判断公司医疗产品的交流信息是否符合药品说明书的基本原则与实例

Basic principles and examples on which FDA to determine whether firms' medical product communications are consistent with FDA-required labeling

美国食品药品管理局(FDA)于2017年1月发布了"符合FDA核准的说明书的医疗产品的交流信息——问答供企业用指导原则",该指导原则介绍了FDA判断公司提出的有关产品应用的交流信息是否符合说明书(即是否在说明书允许的范围内)的基本原则并列举了实例。介绍该指导原则的主要内容,并期望对我国医疗产品交流信息的规范化及其监管有益。

FDA issued Medical Product Communications That Are Consistent With FDA-Required Labeling -- Questions andAnswers Guidance for Industry in January 2017, which introduced basic principles on which FDA to determine whetherfirms＇medical product communications about the use of the product are consistent with the FDA-required labeling （i.e. whether in theallowable range of labeling） and listed examples. This paper introduces the guidance, and is expected to be beneficial to thestandardization and supervision of the medical product communications in China.