研发新冠药药厂礼来据报违规删除药品生产数据 遭监管部门发通知
《路透》引述消息报道,美国食品及药物管理局发现研发新冠治疗药物的礼来药厂(Eli Lilly)厂房在品质监控上出现严重问题,可能影响礼来药厂对其新冠药物寻求紧急认证,因为紧急认证一般需要在药物生产标准上合规。
报道引述政府文件指,调查员去年11月视察礼来药厂位於新泽西州的厂房,发现部分生产程序数据被删除及未有适当地审核。美国食品及药物管理局其後把有关问题列入最严重程度违规,并发出官方行动指示通知(Offical Action Indicated Notice),意味严重性足以对公众健康构成显着影响且需予以解决。
报道指,礼来药厂承认接到有关通知,但拒绝进一步置评。礼来药厂早前宣布,基於潜在安全问题,暂停新冠药物临床测试。
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