• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.

作者信息

Herder Matthew, Morten Christopher J, Doshi Peter

机构信息

Health Law Institute, Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada.

Department of Pharmacology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.

出版信息

JAMA Intern Med. 2020 May 1;180(5):629-630. doi: 10.1001/jamainternmed.2020.0074.

DOI:10.1001/jamainternmed.2020.0074
PMID:32119058
Abstract
摘要

相似文献

1
Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost.美国食品药品监督管理局的综合药物评审——法律问题与知识流失
JAMA Intern Med. 2020 May 1;180(5):629-630. doi: 10.1001/jamainternmed.2020.0074.
2
Food and Drug Administration Drug Approval Process: A History and Overview.食品药品监督管理局药品审批流程：历史与概述
Nurs Clin North Am. 2016 Mar;51(1):1-11. doi: 10.1016/j.cnur.2015.10.007. Epub 2016 Jan 13.
3
Integrated Drug Reviews at the US Food and Drug Administration.
JAMA Intern Med. 2020 Sep 1;180(9):1248-1250. doi: 10.1001/jamainternmed.2020.1981.
4
The Food and Drug Administration's experimental drug approval system: is it good for your health?
Houst Law Rev. 1991 Jan;28(1):309-36.
5
Integrated Drug Reviews at the US Food and Drug Administration-Reply.
JAMA Intern Med. 2020 Sep 1;180(9):1261-1262. doi: 10.1001/jamainternmed.2020.1978.
6
A state of extinction: does Food and Drug Administration approval of a prescription drug label extinguish state claims for inadequate warning?一种失效状态：美国食品药品监督管理局对处方药标签的批准是否使各州关于警示不足的索赔失效？
Food Drug Law J. 2003;58(2):287-97.
7
Off-label prescribing. Legal implications.药品未按说明书用药。法律影响。
J Leg Med. 1999 Sep;20(3):365-83. doi: 10.1080/01947649909511094.
8
Panel eases US drug approval process.
Lancet Oncol. 2004 Feb;5(2):71. doi: 10.1016/s1470-2045(04)01367-1.
9
US Food and Drug Administration pushed to change.美国食品药品监督管理局被迫做出改变。
Lancet. 2006 May 20;367(9523):1643-4. doi: 10.1016/S0140-6736(06)68714-X.
10
Assessment of the Right-to-Try Law: The Pros and the Cons.“尝试权”法评估：利弊分析
J Nucl Med. 2018 Oct;59(10):1492-1493. doi: 10.2967/jnumed.118.216945. Epub 2018 Aug 10.

引用本文的文献

1
Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model.使用输入-过程-输出模型评估美国食品药品监督管理局（FDA）跨学科新药协作审评中的整合情况。
J Clin Transl Sci. 2021 Sep 30;5(1):e199. doi: 10.1017/cts.2021.861. eCollection 2021.
2
Exploring the Food and Drug Administration's review and approval of Entresto (sacubitril/valsartan).探讨食品和药物管理局对 Entresto（沙库巴曲缬沙坦）的审查和批准。
Pharmacol Res Perspect. 2021 May;9(3):e00794. doi: 10.1002/prp2.794.
3
Regulators, Pivotal Clinical Trials, and Drug Regulation in the Age of COVID-19.
监管机构、关键临床试验与新冠疫情时代的药品监管
Int J Health Serv. 2021 Jan;51(1):5-13. doi: 10.1177/0020731420979824.
4
Disagreements Within the US Food and Drug Administration Regarding Approval of Novel Therapeutic Agents, 2011-2015.美国食品和药物管理局在 2011-2015 年期间对新型治疗药物的审批存在分歧。
JAMA Netw Open. 2020 Jul 1;3(7):e209498. doi: 10.1001/jamanetworkopen.2020.9498.