Regulatory Affairs Professionals Society· @RAPSorg · X·· 2026-08-03精选AI 评分55
AI 导读
FDA 于周五发布指南草案，帮助申办方为生物类似药及可互换生物类似药组合产品提供开发容器密封系统和器械组成部分所需的信息。该草案面向组合产品申报中的资料准备环节。
推荐理由
FDA 就生物类似药组合产品的容器密封系统与器械组成部分发布指南草案，涉及申报资料要求。
正文
FDA on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products.
https://hubs.la/Q04rDh670
来源：Regulatory Affairs Professionals Society · x.com