Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
Author:
Affiliation:
1. London School of Economics and Political Science
2. King's College London
Publisher
Wiley
Subject
Public Health, Environmental and Occupational Health,Health Policy
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1111/1468-0009.12476
Reference59 articles.
1. From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients
2. Pharmaceutical Drugs of Uncertain Value, Lifecycle Regulation at the US Food and Drug Administration, and Institutional Incumbency
3. The US Food and Drug Administration’s expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements
4. Accelerated Access to Innovative Medicines for Patients in Need
5. European Medicines Agency.PRIME: A Two‐Year Overview.London England:European Medicines Agency;2018.https://www.ema.europa.eu/en/documents/report/prime-two-year-overview_en.pdf. Accessed October 8 2019.
Cited by 39 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. Recent advances and current challenges in CAR-T cell therapy;Biotechnology Letters;2023-12-27
2. Response to uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group – author’s reply;International Journal of Technology Assessment in Health Care;2023-12-18
3. The Uses of Anabolic Androgenic Steroids Among Athletes; Its Positive and Negative Aspects- A Literature Review;Journal of Multidisciplinary Healthcare;2023-12
4. Pricing and reimbursement mechanisms for advanced therapy medicinal products in 20 countries;Frontiers in Pharmacology;2023-11-28
5. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy;The European Journal of Health Economics;2023-11-14
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