美国食品药品管理局（FDA）于2021年12月发布了"慢性鼻-鼻窦炎伴鼻息肉：开发治疗药物供企业用的指导原则草案"，对慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）治疗药物临床研究的试验人群、设计、有效性、安全性和统计分析提出了许多建议，内容具体、详细，而且便于实际操作。中国目前没有类似的指导原则，详细介绍FDA该指导原则，期待对我国这类药物的临床研究及其监管有直接的参考价值，对制定类似的临床研究指导原则有所启迪。

Food and Drug Administration (FDA) issued the Chronic Rhinosinusitis with Nasal Polyps:Developing Drugs for Treatment Draft Guidance for Industry in December 2021. Many suggestions are put forward on the trial population, design, effectiveness, safety and statistical analysis of the clinical research of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). The content is specific, detailed and convenient for practical operation. At present, there is no similar guidance in China. The guidance of FDA is introduced in detail, which is expected to have direct reference value for the clinical research and supervision of this kind of drugs in China, and also enlighten the formulation of similar guidance for clinical research in China.

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