默沙东研发(中国)有限公司申请I类会议

金融界
21 Jan

金融界1月21日消息,据CDE官网沟通交流公示,于1月21日收到默沙东研发(中国)有限公司申请的“I类会议”,当前状态“处理中”。根据《药物研发与技术审评沟通交流管理办法》(2020年第48号通告),沟通交流会议分为Ⅰ类、Ⅱ类和Ⅲ类会议,就关键阶段重大问题进行沟通交流。Ⅰ类会议一般安排在申请后30日内召开,系指为解决药物临床试验过程中遇到的重大安全性问题和突破性治疗药物研发过程中的重大技术问题,或...

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