Under Pressure to Improve Safety, FDA Slashes Drug Approval Rate

Martin Gidron

首页> 外文期刊>Washington Drug Letter >Under Pressure to Improve Safety, FDA Slashes Drug Approval Rate

【24h】

Under Pressure to Improve Safety, FDA Slashes Drug Approval Rate

机译：在提高安全性的压力下，FDA大幅削减了药品批准率

获取原文

获取原文并翻译 | 示例

获取外文期刊封面封底 >>

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

The FDA's drug approval rate plummeted 13 percent from 2006 to 2007 as the agency came under fire from Congress over safety concerns. Last year the agency issued 22 percent more nonapprovable letters and 40 percent more ap-provable letters to new drug applicants than the year before, Mark Senak of the marketing and communications firm Fleishman-Hillard said during an FDAnews audioconference.

机译：FDA的药品批准率从2006年到2007年暴跌了13％，原因是该机构因安全问题而受到国会的抨击。营销与传播公司Fleishman-Hillard的Mark Senak在FDAnews音频会议上说，去年该机构向新药申请人发出的不可批准信件和可批准信件分别比去年增加了22％和40％。

著录项

来源
《Washington Drug Letter》 |2008年第12期|p.11|共1页
作者
Martin Gidron;
展开▼
作者单位

展开▼
收录信息
原文格式 PDF
正文语种 eng
中图分类生物科学;
关键词

相似文献

外文文献
中文文献
专利

1. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Supplemental Actions Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2011,第9期

机译：当前与FDA有关的药物信息由FDA批准的新药物新剂型和适应症，由FDA代理商批准的待批FDA批准的新药/生物许可申请，由制造商提出的补充措施，由制造商提出的重要措施，或与“亲爱的健康专业人员”的信件有关安全
2. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2011,第8期

机译：当前与FDA有关的药物信息由FDA批准的新药物，由FDA代理批准的新剂型和适应症，待FDA批准的新药物/生物学许可由制造商提交的重要标签变更或与安全相关的“亲爱的健康专业人员”信函
3. Current FDA-Related Drug Information New Drugs Approved by the FDA New Dosage Forms and Indications Approved by the FDA Agents Pending FDA Approval New Drug/Biologies License Applications Filed by Manufacturer Supplemental Applications Filed by Manufacturer Significant Labeling Changes or "Dear Health Professional" Letters Related to Safety [J] . Danial E. Baker Hospital pharmacy. . 2010,第6期

机译：当前与FDA有关的药物信息由FDA批准的新药物，由FDA代理商批准的新剂型和适应症，待FDA批准的制造商提出的新药/生物许可申请，制造商提出的补充申请，重要的标签变更或与“亲爱的健康专业人员”的信件安全
4. Pressure-based contact sensors improve integrated occupant safety in frontal impacts [C] . Bert Lindner, Manfred Kratschmer, Michael Feser, VDI-Fachtagung Fahrzeugsicherheit . 2013

机译：基于压力的接触传感器可提高正面影响的综合乘员安全性
5. Meta-Analysis to Identify and Evaluate Factors Associated with Regulatory Approval of Orphan Drugs (OD) to Develop an Algorithm for Predicting Regulatory Approval (Success) and to Develop a Standardized Tool to Improve Orphan Drug Portfolio Decision-Making [D] . Florent, Milky C. 2019

机译：荟萃分析，以识别和评估与孤儿药物监管批准（OD）相关的因素，以开发预测监管批准（成功）的算法，并开发标准化工具以改善孤儿药物投资组合决策
6. Evaluation of Serious Postmarket Safety Signals Within 2 Years of FDA Approval for New Cancer Drugs [O] . Janice Kim, Abhilasha Nair, Patricia Keegan, 2020

机译：在FDA批准新癌症药物的2年内评估严重的上市后安全信号
7. Theme III: does the FDA approval process for antihypertensive agents assure efficacy, safety and timeliness? Does the FDA approval process for antihypertensive drugs assure efficacy, safety and timeliness? The public health perspective. [O] . B PSATY 1999

机译：主题III：FDA批准过程是否有助于抗高血压药剂来确保疗效，安全性和及时性？ FDA是否批准抗高血压药物的批准过程确保疗效，安全性和及时性？公共卫生视角。

Under Pressure to Improve Safety, FDA Slashes Drug Approval Rate

摘要

著录项

相似文献

相关主题

期刊订阅