美国FDA关于抗菌药物疗效评价的考虑

FDA' s general consideration on the efficacy evaluation of the antibacterial drugs in USA

本文简要介绍了美国食品药品监督管理局对抗菌药物临床试验有效性评价的相关考虑,希望对中国创新性抗菌药物的临床试验的有效性评价有所提示和参考。

This article is to introduce FDA＇s （Food and Drug Administration） general consideration on the efficacy evaluation of the antibacterial drugs, in order to give some suggestion to evaluate efficacy in new antibacterial agent clinical trials in China.