美国食品药品管理局（FDA）于2018年1月公布了“人用处方药和生物制品处方资料要点中的产品标题和美国首次批准——内容和格式行业指导原则”，提出了药品说明书中关于人用处方药和生物制品的产品标题和美国首次批准年份的内容和格式的撰写建议。介绍FDA该指导原则的主要内容，为细化我国药品说明书指导原则提供参考。

FDA announced Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products - Content and Format Guidance for Industry in January 2018. This guidance provides recommendations on the content and format of the product title and year of initial U.S. approval for human prescription drug and biological products. This paper introduces the main content of the guideline in order to provide references for the refinement of guidance for prescription drug instruction in China.