美國(guó)食品藥品監(jiān)督管理局（FDA）于2019年7月發(fā)布了“使用說(shuō)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(shuō)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(duì)IFU的內(nèi)容和格式提出了建議。提供專為患者閱讀的說(shuō)明書是國(guó)際慣例，IFU只是這類說(shuō)明書的一種，而中國(guó)目前尚無(wú)這種說(shuō)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(shuō)明書早日在中國(guó)問(wèn)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.