美國食品藥品監(jiān)督管理局（FDA）于2020年6月發(fā)布了“供企業(yè)用社區(qū)獲得性細(xì)菌性肺炎：治療藥物開發(fā)指導(dǎo)原則”。該指導(dǎo)原則闡述了FDA目前對支持治療社區(qū)獲得性細(xì)菌性肺炎適應(yīng)癥藥物的總體開發(fā)方案和臨床試驗設(shè)計的看法。詳細(xì)介紹該指導(dǎo)原則，期望對中國“社區(qū)獲得性細(xì)菌性肺炎抗菌藥物研發(fā)臨床試驗技術(shù)指導(dǎo)原則（征求意見稿）”的修訂以及這類藥物的臨床研究和監(jiān)管有幫助。

FDA released Community-Acquired Bacterial Pneumonia:Developing Drugs for Treatment Guidance for Industry June 2020. This guidance described the FDA's current thinking about the overall development program and clinical trial designs for drugs to support an indication for the treatment of CABP. The guidance is described in detail. It is expected to be helpful to the revision of Technical guidelines for clinical trials of antimicrobial agents for community-acquired bacterial pneumonia (Draft), as well as the clinical trial and supervision of such drugs in China.

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