首页> 美国卫生研究院文献>other >A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

【2h】

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

机译：2007年至2013年FDA和EMA授予小儿药物开发豁免的比较回顾

代理获取

本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。

页面导航

摘要
著录项
相似文献
相关主题

摘要

BackgroundThe European Union and the United States have different legal frameworks in place for pediatric drug development, which can potentially lead to different pediatric research requirements for the pharmaceutical industry. This manuscript compares pediatric clinical trial waivers granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

机译：背景欧盟和美国针对儿科药物开发制定了不同的法律框架，这可能会导致制药行业对儿科研究的要求不同。该手稿比较了欧洲药品管理局（EMA）和美国食品药品监督管理局（FDA）授予的儿科临床试验豁免。

著录项

期刊名称 other
作者
Gunter F. Egger; Gerold T. Wharton; Suzanne Malli; Jean Temeck; M. Dianne Murphy; Paolo Tomasi;
展开▼
作者单位

展开▼
年(卷),期 -1(50),5
年度 -1
页码 639–647
总页数 15
原文格式 PDF
正文语种
中图分类
关键词
Pediatric Regulation Pediatric Research Equity Act Paediatric Committee (PDCO) Pediatric Review Committee (PeRC) Best Pharmaceuticals for Children Act drug regulation in children;

机译：儿科法规;儿科研究公平法;儿科委员会（PDCO）;儿科审查委员会（PeRC）;最佳儿童药物法案;儿童药物法规;

相似文献

外文文献
中文文献

1. A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA From 2007-2013 [J] . Egger Gunter F., Wharton Gerold T., Malli Suzanne, Therapeutic innovation & regulatory science. . 2016,第5期

机译：2007年至2013年FDA和EMA授予小儿药物开发豁免的比较回顾
2. Comparison of Drug Approvals in Europe Versus the United States: An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA [J] . Robert W. Makuch, Ruizhi Shi Drug information journal . 2014,第3期

机译：欧洲与美国的药品批准比较：EMA和FDA审查的药品之间的差异分析
3. Comparison of Drug Approvals in Europe Versus the United States: An Analysis of Discrepancies Between Drug Products Reviewed by EMA and FDA [J] . Makuch Robert W., Shi Ruizhi Therapeutic innovation & regulatory science. . 2014,第3期

机译：欧洲与美国的药品批准比较：EMA和FDA审查的药品之间的差异分析
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. Technical communication and the development of a Request for Designation (RFD) submission to the U.S. Food and Drug Administration (FDA). [D] . Bodary, Michael J. 2011

机译：技术交流和向美国食品药品管理局（FDA）提交的指定要求（RFD）的开发。
6. FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis [O] . Chandra P. Leo, Bettina Hentschel, Thomas D. Szucs, 2020

机译：FDA和EMA批准了新的乳腺癌药物-比较法规分析
7. P84 Pediatric oncology studies triggered by the united states (US) food and drug administration (FDA) and the european union (EU) european medicines agency (EMA) aim at labels, not at improved treatment. Some harm young patients by exposing them to substandard monotherapy instead of combination treatment [O] . K Rose 2019

机译：由美国（美国）食品和药物管理局（FDA）和欧洲联盟（欧盟）欧洲药物局（EMA）瞄准标签，而不是改善治疗的欧洲药物和药物肿瘤学研究。一些伤害年轻患者通过将它们暴露于不合标准的单疗法而不是组合治疗
8. Comparative History of FDA'S (Food and Drug Administration) Retrospective Reviews [R] . Condraski, S. J. 1982

机译：FDa的比较历史（食品和药物管理局）回顾性评论

A Comparative Review of Waivers Granted in Pediatric Drug Development by FDA and EMA from 2007-2013

摘要

著录项

相似文献

相关主题

期刊订阅