Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration

被引：0
作者：
Alexander Egilman
Joshua D. Wallach
Jeremy Puthumana
Audrey D. Zhang
Jason L. Schwartz
Joseph S. Ross
机构：
[1] Yale-New Haven Hospital,Center for Outcomes Research and Evaluation
[2] Yale School of Public Health,Department of Environmental Health Sciences
[3] Yale School of Medicine,Department of Internal Medicine
[4] Duke University School of Medicine,Department of Medicine
[5] Yale School of Public Health,Department of Health Policy and Management
来源：
Journal of General Internal Medicine | 2021年 / 36卷
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摘要：
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页码：3281 / 3284
页数：3
相关论文
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  • [2] Bateman-House A(2014)Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012 JAMA. 311 368-77
  • [3] Joffe S(2021)Speed, evidence, and safety characteristics of vaccine approvals by the US Food and Drug Administration JAMA Intern Med. 181 559-36
  • [4] Downing NS(2017)Characteristics of preapproval and postapproval studies for drugs granted accelerated approval by the US Food and Drug Administration JAMA. 318 626-60
  • [5] Aminawung JA(2020)Ethical and scientific considerations regarding the early approval and deployment of a COVID-19 vaccine Ann Intern Med. 174 258-undefined
  • [6] Shah ND(undefined)undefined undefined undefined undefined-undefined
  • [7] Krumholz HM(undefined)undefined undefined undefined undefined-undefined
  • [8] Ross JS(undefined)undefined undefined undefined undefined-undefined
  • [9] Puthumana J(undefined)undefined undefined undefined undefined-undefined
  • [10] Egilman AC(undefined)undefined undefined undefined undefined-undefined
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