主题：【原创】关于RCT与RWS -- 懒厨
跟你要个链接真是难，不到源头找给你，你都不死心：
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？
- 相关回复 上下关系8
压缩 13 层
🙂不至于连个新闻都查不对吧？ 2 qq97 字475 2021-10-08 22:43:59
🙂那你就给个链接嘛 懒厨 字45 2021-10-08 22:46:36
🙂你要想看到，自然能查到 qq97 字75 2021-10-08 23:01:17
🙂这是授权使用，不是试验。平级按原文是以FDA意见为基础的。 1 月之回忆 字335 2021-10-08 11:17:06
🙂紧急授权肯定有相应的流程 懒厨 字318 2021-10-08 11:48:48
