Drug Safety Board's Advice Not Sought on FDA Avandia Deliberations

David Belian

首页> 外文期刊>Washington Drug Letter >Drug Safety Board's Advice Not Sought on FDA Avandia Deliberations

【24h】

Drug Safety Board's Advice Not Sought on FDA Avandia Deliberations

机译：未就FDA Avandia审议寻求药物安全委员会的建议

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

As the FDA continues its internal deliberations on whether to keep GlaxoSmithKline's (GSK) diabetes drug Avandia on the market, the agency's internal Drug Safety Oversight Board (DSB) is not participating in the discussions because it hasn't been asked by CDER officials to provide input.rn"The board is aware of [Avandia (rosiglita-zone)] being in the news, but the board has to be asked to discuss it," Steven Osborne, executive director of the board, said during a press briefing Wednesday. "It's a [possibility], but the drug has not been discussed."

机译：随着FDA继续就是否将葛兰素史克（GSK）糖尿病药物Avandia投放市场进行内部讨论，该机构的内部药物安全监督委员会（DSB）并未参与讨论，因为CDER官员并未要求其提供董事会执行董事史蒂芬·奥斯本在周三的新闻发布会上说：“董事会已经知道[Avandia（rosiglita-zone）]出现在新闻中，但是必须要求董事会进行讨论。” “这是（可能），但尚未讨论该药。”

著录项

来源
《Washington Drug Letter》 |2010年第34期|P.3|共1页
作者
David Belian;
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
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. COMMUNICATION OF DRUG HAZARD INFORMATION:A CRITICAL ANALYSIS OF THE RELATIONSHIP BETWEEN THE PHARMACEUTICAL INDUSTRY, FDA, CLINICIANS, AND PATIENTS AND THE IMPACT ON PATIENT SAFETY [C] . Alison G. Vredenburgh, Matthew B. Weinger Proceedings of the Human Factors and Ergonomics Society 48th annual meeting (HFES 2004) . 2004

机译：药物危害信息的传播：对制药业，FDA，临床医生和患者之间关系以及对患者安全影响的关键分析
5. Safety and Effectiveness: The FDA's Approach to Risk in Prescription Medication. [D] . Philip Gentry, Elissa. 2016

机译：安全性和有效性：FDA处方药风险管理方法。
6. FDA hearings leave doctors patients in limbo on Avandia [O] . Laura Eggertson, Cal Woodward 2010

机译：FDA听证会使医生患者陷入困境
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。
8. Advances in FDAs Safety Program for Marketed Drugs: Establishing Premarket Safety Review and Marketed Drug Safety as Equal Priorities at FDAs Center for Drug Evaluation and Research. [R] . 2012

机译：FDas安全计划在市场营销中的应用：在FDas药物评估和研究中心建立上市前安全审查和上市药物安全作为平等优先事项。

Drug Safety Board's Advice Not Sought on FDA Avandia Deliberations

摘要

著录项

相似文献

相关主题

期刊订阅