美國食品藥品監(jiān)督管理局（FDA）于2019年7月發(fā)布了“使用說明書（IFU）——人用處方藥和生物制品以及藥品-器械和生物制品-器械組合產(chǎn)品的患者用說明書——內(nèi)容和格式供企業(yè)用指導(dǎo)原則（草案）”，該指導(dǎo)原則對IFU的內(nèi)容和格式提出了建議。提供專為患者閱讀的說明書是國際慣例，IFU只是這類說明書的一種，而中國目前尚無這種說明書。詳細(xì)介紹該指導(dǎo)原則的主要內(nèi)容，期待通俗易懂的患者用說明書早日在中國問世。

The FDA issued the Instructions for Use-Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products-Content and Format Guidance for Industry (Draft) in July 2019. The guidance provided suggestions on the content and format of the Instructions for Use (IFU). It is an international practice to provide specific Patient Labeling. IFU is just one of these Labelings. At present, there is no such Labelings in our country. This paper introduces the guidance in detail and calls for the publication of easy-to-understand patient Labelings in China.