美国食品药品监督管理局（FDA）于2023年11月发布了"糖尿病足感染：开发治疗药物的供企业用的指导原则（草案）"。该指导原则草案提出了糖尿病足感染治疗药物临床开发的建议，包括对这类药物临床试验设计关键要素的许多具体建议，如试验设计、试验人群、疗效评估等方面。而我国目前尚没有类似的指导原则。详细介绍FDA该指导原则草案，期望对我国这类药物开发的临床研究及其评价有所裨益。

The U.S. Food and Drug Administration (FDA) issued the "Diabetic Foot Infections:Developing Drugs for Treatment Guidance for Industry (Draft)" in November 2023. This draft guidance offers recommendations for the clinical development of therapeutic drugs for diabetic foot infections, including numerous specific suggestions for key elements in the clinical trials of such drugs, such as trial design, trial population, efficacy evaluation, etc. Currently, there is no similar guidance available in China. This article provides a detailed introduction to the FDA's draft guidance, with the hope of benefiting the clinical research and evaluation of drug development of this type in China.

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