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Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals

机译：从美国食品药品监督管理局批准到癌症药物数据发布的时间：首次批准与后续批准的比较

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期刊名称 Blood Cancer Journal
作者
Austin Lammers; Ruibin Wang; Jeremy Cetnar; Vinay Prasad;
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作者单位

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年(卷),期 2017(7),12
年度 2017
页码 637
总页数 4
原文格式 PDF
正文语种
中图分类肿瘤学;
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1. The US Food and Drug Administration's use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation [J] . DeLoughery E. P., Prasad V. Annals of oncology: official journal of the European Society for Medical Oncology . 2018,第3期

机译：美国食品和药物管理局对基于单臂研究的癌症药物定期批准：对后续证据生成的影响
2. The US Food and Drug Administration's use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation [J] . DeLoughery E. P., Prasad V. Annals of oncology: official journal of the European Society for Medical Oncology . 2018,第3期

机译：美国食品和药物管理局对基于单臂研究的癌症药物定期批准：对后续证据生成的影响
3. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals [J] . Kim Chul, Prasad Vinay JAMA internal medicine . 2015,第12期

机译：根据替代终点和随后的总体生存率批准的抗癌药物：对美国食品药品监督管理局批准的5年的分析
4. Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review [C] . Samuel A. Bonet, Farzan Sasangohar, Mark Lawley Human Factors and Ergonomics Society annual meeting . 2018

机译：调查食品和药物管理局（FDA）生物治疗审查和审批过程：审查审查
5. The Food and Drug Administration's new drug approvals and market withdrawals for safety under the Prescription Drug User Fee Act and the Food and Drug Modernization Act. [D] . Dziurzynski, Bogdan. 2005

机译：食品和药物管理局根据《处方药使用者费用法》和《食品和药物现代化法》为安全起见批准了新药，并撤出了市场。
6. Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval [O] . Roberta Joppi, Vittorio Bertele, Tommaso Vannini, 2020

机译：食品和药物管理局与欧洲药物局：在批准时审查时间和新药的临床证据
7. Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals [O] . Austin Lammers, Ruibin Wang, Jeremy Cetnar, 2017

机译：从美国食品和药物管理局批准对癌症药物的数据发表的时间：比较第一和后续批准
8. Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities [R] . 2002

机译：食品药品监督管理局：用户费用对药品批准时间，取款和其他代理商活动的影响

Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals

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