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

关键词：

D O I：

暂无

中图分类号：

学科分类号：

摘要：

引用

页码：3281 / 3284

页数：3

共 20 条

[1]

Lynch HF(2020)Emergency approvals for COVID-19: evolving impact on obligations to patients in clinical care and research Ann Intern Med. 174 256-7

[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]

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