美國食品和藥品管理局（FDA）于2013年9月發(fā)布了“人用處方藥和生物制品說明書[患者須知]部分內容和形式（草案）”的指導原則。介紹其中對[患者須知]內容和形式的要求并說明其產生的背景，特別是法律依據。目前我國處方藥說明書專業(yè)性很強，沒有設置[患者須知]項目，也無針對患者的說明書。綜述了FDA該指導原則的主要內容，期望為打開我國說明書直面患者的大門起到一定的積極作用。

FDA issued “Guidance for Industry Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (Draft)” in September of 2013. This paper introduces the requirements for the content and format of patient counseling information section and explains its background, especially the legal basis. In our country the prescription drug labeling is very professional and does not include patient counseling information section. There is also no patient labeling. This paper introduces the main contents of the guidance of FDA. It is expected to play an active role in opening the door of our labeling directly toward patients.