美國聯(lián)邦法規(guī)對處方藥說明書[適應(yīng)癥和應(yīng)用]項的撰寫內(nèi)容和原則做了詳細(xì)規(guī)定。2014 年，F(xiàn)DA 又發(fā)布了“按照加快審批管理途徑批準(zhǔn)的人用處方藥和生物制品的說明書”的指導(dǎo)原則（草案），特別強調(diào)根據(jù)測定早于可逆性病況或死亡出現(xiàn)的替代終點或臨床終點批準(zhǔn)藥品的說明書，[適應(yīng)癥和應(yīng)用]項應(yīng)包括藥物應(yīng)用限制和預(yù)期臨床受益不確定性的簡要描述。列舉實例介紹這兩個文件的主要內(nèi)容，希望對改變目前我國藥品說明書[適應(yīng)癥]內(nèi)容描述不夠嚴(yán)謹(jǐn)、應(yīng)用限制和預(yù)期臨床受益不確定性描述普遍缺失、內(nèi)容不夠具體的狀況有所幫助和啟發(fā)。

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.