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The approval of Aduhelm risks eroding public trust in Alzheimer research and the FDA
Nature Reviews Neurology ( IF 28.2 ) Pub Date : 2021-07-15 , DOI: 10.1038/s41582-021-00540-6
Jason Karlawish 1 , Joshua D Grill 2
Affiliation  

The FDA has granted accelerated approval to aducanumab (Aduhelm) for the treatment of Alzheimer disease with an overly broad label. The decision disregarded key aspects of scientific process and risks eroding public trust in research, regulatory science and the FDA.

中文翻译:


Aduhelm 的批准可能会削弱公众对阿尔茨海默病研究和 FDA 的信任



FDA 加速批准 aducanumab (Aduhelm) 用于治疗标签过于宽泛的阿尔茨海默病。该决定忽视了科学过程的关键方面,并存在削弱公众对研究、监管科学和 FDA 信任的风险。
更新日期:2021-07-15
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