How User Fees Have Altered US Drug Regulation

The Regulatory Affairs Journal

首页> 外文期刊>The regulatory affairs journal: Pharma >How User Fees Have Altered US Drug Regulation

【24h】

How User Fees Have Altered US Drug Regulation

机译：使用者费用如何改变了美国药品法规

获取原文

获取原文并翻译 | 示例

掌桥外文数据库（机构版） >>

开具论文收录证明 >>

文献代查 >>

页面导航

摘要
著录项
相似文献
相关主题

摘要

One of the key structural changes to the United States Food and Drug Administration (FDA) came about in 1992 with the passage of the Prescription Drug User Fee Act (PDUFA). This landmark piece of legislation addressed a critical public health problem in the United States, namely the delay in the approval of important new drugs. At the end of the 1980s the new drug approval time was about 29 months following submission of a license application. Remarkably, many important new drugs were approved in overseas markets first before they were licensed in the US. While many reasons have been cited for this state of affairs, the principal problem was a lack of agency resources to accomplish the job of reviewing lengthy and complex regulatory submissions in a timely manner.

机译：1992年，随着《处方药使用者费用法案》（PDUFA）的通过，对美国食品和药物管理局（FDA）进行了重要的结构改革之一。这项具有里程碑意义的立法解决了美国的关键公共卫生问题，即延迟批准重要的新药。在1980年代末，新药批准时间大约是在提交许可证申请后的29个月。值得注意的是，许多重要的新药先在海外市场获得批准，然后再在美国获得许可。尽管有许多原因导致这种情况发生，但主要的问题是缺乏机构资源来完成及时审查冗长而复杂的监管意见的工作。

著录项

来源
《The regulatory affairs journal: Pharma》 |2004年第6期|共6页
作者
The Regulatory Affairs Journal;
展开▼
作者单位

展开▼
收录信息
原文格式 PDF
正文语种 eng
中图分类药学;
关键词

相似文献

外文文献
中文文献
专利

1. How User Fees Have Altered US Drug Regulation [J] . The Regulatory Affairs Journal The regulatory affairs journal: Pharma . 2004,第6期

机译：使用者费用如何改变了美国药品法规
2. The effect of user fees on prescribing quality in rural Nepal: two controlled pre-post studies to compare a fee per drug unit vs. a fee per drug item. [J] . Holloway KA, Karkee S, Tamang A, Tropical Medicine and International Health: TM and IH . 2008,第4期

机译：使用者费用对尼泊尔农村地区处方质量的影响：两项对照的事前研究，比较了每个药物单位的费用与每个药物项目的费用。
3. FDA Readies New Guidance and User Fee Program for Biosimilars Drug interchangeability and user fees are contentious issues the FDA must resolve. Is the FDA up to the task? [J] . STEPHEN BARLAS Biotechnology healthcare . 2012,第2期

机译：FDA准备针对生物仿制药的新指南和使用者费用计划药物互换性和使用者费用是FDA必须解决的有争议的问题。 FDA是否可以胜任这项任务？
4. A REAL WORLD TEST OF ROAD USER FEES: EVALUATING MINNESOTA'S MILEAGE-BASED USER FEE TEST [C] . Christopher Armstrong, Nicholas Kehoe, Sheryl Miller, Transportation Research Board Annual meeting . 2013

机译：道路用户费用的真实测试：评估明尼苏达州基于里程的用户费用测试
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. Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items [O] . Huyi Zhang, Haitao Li, Wei Song, 2014

机译：仿制药使用者费用修正案下第二类活性药物成分药物主文件的完整性评估：审查指标和常见不完整项目
7. The effect of user fees on prescribing quality in rural Nepal: two controlled pre-post studies to compare a fee per drug unit vs. a fee per drug item [O] . Kathleen A. Holloway, Shiva Karkee, Ashalal Tamang, 2008

机译：用户费用对尼泊尔农村规定质量的影响：两项控制前研究，以比较每种药物单位的费用与每种药物的费用
8. PDUFA Financial Report (FY 2004) Required by the Prescription Drug User Fee Act of 1992 as Amended by the Food and Drug Administration Modernization Act of 1997 and by the Prescription Drug User Fee Amendments of 2002 [R] . 2005

机译：pDUFa财务报告（2004财年）根据1997年食品药品管理局现代化法案和2002年处方药用户费修正案修订的1992年处方药用户费法案要求

How User Fees Have Altered US Drug Regulation

摘要

著录项

相似文献

相关主题

期刊订阅