比较美国食品药品监督管理局、欧洲药品管理局和加拿大卫生部批准的 COVID-19 疫苗。
Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada.
机构信息
Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, United Kingdom.
Department of Metabolism, Digestion and Reproduction, Imperial College London, St Mary's Hospital, United Kingdom.
出版信息
JAMA Netw Open. 2021 Jun 1;4(6):e2114531. doi: 10.1001/jamanetworkopen.2021.14531.
Abstract
This qualitative improvement study investigates COVID-19 vaccine approvals at 3 medicine regulatory agencies in the US, EU, and Canada, characterizing and contrasting regulatory review times, and analyzing the clinical evidence supporting authorization.
摘要
这项定性改进研究调查了美国、欧盟和加拿大的 3 个药品监管机构的 COVID-19 疫苗批准情况，描述和对比了监管审查时间，并分析了支持授权的临床证据。
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本文引用的文献
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