CAR-T疗法诞生以来，安全性一直是悬在头上的达摩克利斯之剑。CRS、ICANS以及长期安全信号，是无法逃避的话题。日前，FDA的几位高管在Annals of Interal Medicine上发表的一篇文章很好地阐述了他们的立场：将以灵活的监管方法支持这些新型细胞疗法的开发。
We’ll apply a selective screening process on applications. At this stage, we’re primarily going to look for signals that worked well for us in the past & what we outlined in the “What we are looking for” section.
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