Regulatory Affairs Professionals Society· @RAPSorg · X·· 6 天前精选AI 评分40
AI 导读
在讨论《仿制药使用者付费法案》（GDUFA）再授权的公开会议上，消费者健康团体敦促FDA为仿制药检测分配更多资源，并对上市后安全报告实施更严格的指标。
推荐理由
消费者健康团体在GDUFA再授权公开会议上提出增加仿制药检测资源与收紧上市后安全报告指标的具体诉求。
正文
Consumer health groups urged FDA to allocate more resources for testing generic drugs and to implement stricter metrics for postmarket safety reporting at a public meeting on Thursday discussing the reauthorization of the Generic Drug User Fee Amendments.
https://hubs.la/Q04yc9FD0
来源：Regulatory Affairs Professionals Society · x.com