The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation-Reference-Cited by-同舟云学术

登录注册会员服务联系我们

The US Food and Drug Administration’s expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

Published:2018-06 Issue:3 Volume:15 Page:243-246
ISSN:1740-7745
Container-title:Clinical Trials
language:en
Short-container-title:Clinical Trials

Author:

Wallach Joshua D¹,Ross Joseph S²,Naci Huseyin³

Affiliation:

1. Collaboration for Research Integrity and Transparency, Yale School of Medicine, New Haven, CT, USA

2. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA

3. LSE Health, Department of Health Policy, The London School of Economics and Political Science, London, UK

Publisher

SAGE Publications

Subject

Pharmacology,General Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/1740774518770657

Reference21 articles.

1. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements

2. Expedited and facilitated drug evaluations and evidence of benefit and risk: The cup is half-full

3. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

4. A Lifecycle Approach to the Evaluation of FDA Approval Methods and Regulatory Actions

5. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration

Cited by 10 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017;JAMA Health Forum;2022-05-27

2. US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009–2018;Clinical Trials;2021-04-16

3. U.S. Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018;2020-09-02

4. Generating comparative evidence on new drugs and devices before approval;The Lancet;2020-03

5. Generating comparative evidence on new drugs and devices after approval;The Lancet;2020-03

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线，采集、加工和组织学术论文而形成的新型学术文献查询和分析系统，可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容，当前同舟云学术共收录了国内外主流学术期刊6万余种，收集的期刊论文及会议论文总量共计约1.5亿篇，并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询！咨询电话：010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号京ICP备18003416号-3