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[摘要]
美国食品药品管理局(FDA)于2017年8月发布了"供企业用未满足治疗严重细菌性疾病医疗需要患者的抗菌治疗指导原则"。该指导原则以问答的形式说明FDA目前对没有或缺乏有效治疗的严重细菌性疾病的新抗菌药简化开发方案和临床试验设计的观点。以问答的形式介绍该指导原则的全部内容,以期对加速我国新抗菌药的研发及其管理有所裨益。
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[Abstract]
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.
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