Regulatory Affairs Professionals Society· @RAPSorg · X·· 3 小时前精选AI 评分62
AI 导读
行业团体及其他利益相关方普遍支持 FDA 近期发布的草案指南，该指南说明在何种情况下可用单关键试验加确证性证据支持药品和生物制品的获批。相关链接：https://hubs.la/Q04yVrdP0
推荐理由
FDA 单臂关键试验加确证性证据的草案指南获得行业普遍支持，可了解监管对证据门槛的取向。
正文
Industry groups and other stakeholders are generally supportive of FDA’s recent draft guidance explaining when single pivotal trials plus confirmatory evidence can be used to support the approval of drugs and biologics.
https://hubs.la/Q04yVrdP0
来源：Regulatory Affairs Professionals Society · x.com