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21健讯Daily|上海医药子公司被曝假处方事件;恒瑞医药PD-1重新在美 ...
21点评:今年5月,恒瑞医药曾公告显示,该PD-1联用方案上市申请遭到FDA拒绝,原因是生产相关的问题。根据公告,FDA需要全面评估企业在生产场地检查缺陷的完整答复,并且由于部分国家的旅行限制,FDA在审查周期内无法完成该项目必需的生物学研究监测计划临床检查。
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