美國食品藥品管理局（FDA）于2018年1月公布了“人用處方藥和生物制品處方資料要點中的產(chǎn)品標(biāo)題和美國首次批準(zhǔn)——內(nèi)容和格式行業(yè)指導(dǎo)原則”，提出了藥品說明書中關(guān)于人用處方藥和生物制品的產(chǎn)品標(biāo)題和美國首次批準(zhǔn)年份的內(nèi)容和格式的撰寫建議。介紹FDA該指導(dǎo)原則的主要內(nèi)容，為細(xì)化我國藥品說明書指導(dǎo)原則提供參考。

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.