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FDA罕见举动警示仿制药商,CRO能载汝亦能覆汝
最近正处于大规模裁员风波之中的FDA做出了一项不太常见的决定,即以CRO(合同研究组织)提供数据存疑为由勒令仿制药开发商重新进行研究。如今制药公司被监管机构拒绝的高危雷区看来又要增加一处。 FDA日前对总部位于印度新孟买(Navi Mumbai)的合同研究组织(CRO)Raptim Research Pvt.
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