Regulatory Affairs Professionals Society· @RAPSorg · X·· 2026-08-26精选AI 评分62
AI 导读
FDA 生物制品审评与研究中心（CBER）发布指南，帮助申办方评估主动免疫治疗产品的效力试验，涵盖癌症疫苗和自身免疫性疾病治疗产品。指南原文链接见 https://hubs.la/Q04vlNLk0。
推荐理由
FDA 生物制品审评与研究中心发布效力试验指南，涉及肿瘤疫苗与自身免疫病治疗产品的申报要求。
正文
FDA's Center for Biologics Evaluation and Research has issued a guidance to assist sponsors in assessing potency assays for active immunotherapy products, including cancer vaccines and treatments for autoimmune diseases.
https://hubs.la/Q04vlNLk0
来源：Regulatory Affairs Professionals Society · x.com