Regulatory Affairs Professionals Society· @RAPSorg · X·· 2026-07-23精选AI 评分60
AI 导读
FDA 向多家药企发出警告信，指其未满足现行药品生产质量管理规范（cGMP）要求；另有一家公司因未向受试者充分告知其所参与的临床试验而被发警告信。
推荐理由
FDA 向多家药企发出警告信，涉及 cGMP 缺陷与临床试验受试者知情告知不足两类问题。
正文
FDA has issued warning letters to several drug makers for failing to meet its current good manufacturing practices requirements and a company for failing to sufficiently inform subjects about the clinical trial they were participating in.
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来源：Regulatory Affairs Professionals Society · x.com