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主题:【原创】关于RCT与RWS -- 懒厨

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家园 那就看看FDA怎么说的嘛

跟你要个链接真是难,不到源头找给你,你都不死心:

https://www.fda.gov/drugs/news-events-human-drugs/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectivenes

To help meet this need, the agency is helping to speed the development of promising therapies through its Coronavirus Treatment Acceleration Program (CTAP).

FDA also revised the EUA for Veklury, originally issued on May 1, 2020, to permit the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.

两点:

其一, 此次审批走的根本不是正常程序,是专为新冠而定的CTAP

其二,为了过审,FDA还特意修改了紧急授权使用的程序

凭这两点,能够说这是正常的流程吗?

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