美國(guó)食品藥品管理局（FDA）于2017年8月發(fā)布了"供企業(yè)用未滿足治療嚴(yán)重細(xì)菌性疾病醫(yī)療需要患者的抗菌治療指導(dǎo)原則"。該指導(dǎo)原則以問(wèn)答的形式說(shuō)明FDA目前對(duì)沒(méi)有或缺乏有效治療的嚴(yán)重細(xì)菌性疾病的新抗菌藥簡(jiǎn)化開發(fā)方案和臨床試驗(yàn)設(shè)計(jì)的觀點(diǎn)。以問(wèn)答的形式介紹該指導(dǎo)原則的全部?jī)?nèi)容，以期對(duì)加速我國(guó)新抗菌藥的研發(fā)及其管理有所裨益。

FDA issued Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases Guidance for Industry in August 2017. This guidance explains the current thinking of FDA in the form of Q & A. It is related to the streamlined development programs and clinical trial designs for antibacterial drugs to treat serious bacterial diseases for which effective antibacterial drugs are limited or lacking. This paper introduces all Q & A of the guideline and expects to be beneficial to accelerate the R & D and management of new antibacterial drugs in our country.