美国联邦法规对处方药说明书[适应症和应用]项的撰写内容和原则做了详细规定。2014 年，FDA 又发布了“按照加快审批管理途径批准的人用处方药和生物制品的说明书”的指导原则（草案），特别强调根据测定早于可逆性病况或死亡出现的替代终点或临床终点批准药品的说明书，[适应症和应用]项应包括药物应用限制和预期临床受益不确定性的简要描述。列举实例介绍这两个文件的主要内容，希望对改变目前我国药品说明书[适应症]内容描述不够严谨、应用限制和预期临床受益不确定性描述普遍缺失、内容不够具体的状况有所帮助和启发。

Code of Federal Regulations set detailed rules for the written content and principle on "Indications and Usage" section of labeling for prescription drugs. In 2014, FDA issued Guidance for Industry Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (draft), with particular emphasis on that "Indications and Usage" section of labeling for drugs approved based on a surrogate or clinical endpoint can be measured earlier than irreversible morbidity or mortality. This section should include a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits. This paper introduces the main contents of these two documents and gives examples. It is expected to help changing the present situation that the description of content on "Indications and Usage" section of labeling is not strict enough, and the description of the limitations of usefulness and any uncertainty about anticipated clinical benefits is generally absent in our country. It enlightens us on changing the situation that our regulation on "Indications and Usage" section of labeling is only a matter of principle, but not specific enough.