Regulatory Affairs Professionals Society· @RAPSorg · X·· 6 小时前AI 评分22
AI 导读
FDA 是否会接受来自美国境外的临床证据，取决于这些研究是否遵循了药物临床试验质量管理规范，但相关数据还应适用于监管目的。 https://hubs.la/Q04yqCsP0
正文
Whether the FDA will accept clinical evidence from outside the United States depends on if the investigations followed good clinical practice regulations, but the data should also be applicable for regulatory purposes.
https://hubs.la/Q04yqCsP0
来源：Regulatory Affairs Professionals Society · x.com