Waxman: Planned Guidance Could Open Loophole for Off-Label Promotio

April Astor

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Waxman: Planned Guidance Could Open Loophole for Off-Label Promotio

机译：韦克斯曼：计划的指导可能会为标外促销打开漏洞

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Rep. Henry Waxman (D-Calif.) is urging the FDA not to release a guidance allowing drug and medical device companies to use journal articles to promote off-label use of their products. Waxman released a copy of the draft guidance, which has not yet been issued by the agency, and sent a letter to the FDA requesting that it not continue work on the document until it provides further information to the House Oversight and Government Reform Committee.

机译：众议员亨利·瓦克斯曼（Henry Waxman）（D-Calif。）敦促FDA不要发布允许药品和医疗器械公司使用期刊文章来促进其产品的标签外使用的指南。瓦克斯曼（Waxman）发布了该指南草案的副本，该指南尚未由该机构发布，并致函FDA，要求在继续向众议院监督和政府改革委员会提供进一步信息之前，不要继续处理该文件。

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《Washington Drug Letter》 |2007年第48期|p.16|共2页
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April Astor;
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中图分类生物科学;
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1. Waxman Questions Origins, of Off-Label Promotion Guidance [J] . Emily Ethridge Washington Drug Letter . 2008,第4期

机译：Waxman质疑标签外促销指南的由来
2. Consumers Union Supports Waxman Opposition to Off-Label Guidance [J] . Emily Ethridge Washington Drug Letter . 2007,第49期

机译：消费者联盟支持Waxman反对非标指导
3. GMC shelves plans to relax off-label prescribing guidance [J] . The pharmaceutical journal Group The pharmaceutical journal . 2012,第7704期

机译：GMC上架计划放松标签外处方指导
4. Off-label Use of Medical Devices in Cardiovascular Medicine-When the Final Decision About the Safety and Effectiveness Is Needed [C] . David Macku World Congress on Medical Physics and Biomedical Engineering . 2019

机译：在需要心血管中的医疗设备的标签使用 - 当需要对安全和有效性的最终决定时
5. Application of the Waxman Smits model for estimating groundwater quality from in situ measurements of electrical conductivity. [D] . Leszkowicz, John Kasimir. 2003

机译：Waxman Smits模型在通过电导率的现场测量估算地下水质量中的应用。
6. New FDA Guidance on Off-Label Promotion Falls Short for Everyone [O] . Stephen Barlas 2009

机译：新的FDA关于非标促销的指导对每个人都不够
7. Neurological commentary addressing the article titled “Guidance for switching from off-label antipsychotics to pimavanserin for Parkinson’s disease psychosis: an expert consensus” [O] . Neal Hermanowicz 2018

机译：神经系统评论解决了标题的文章，标题为“从非标志性抗抗皱核素切换到Pimavanserin的指导，用于Pimavanserin for Pimavanserin：专家共识”

Waxman: Planned Guidance Could Open Loophole for Off-Label Promotio

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