FDA Forces LABA Drugmakers To Change Label, Add REMS

LaCrisha Butler

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FDA Forces LABA Drugmakers To Change Label, Add REMS

机译：FDA强迫LABA药品制造商更改标签，添加REMS

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The FDA has flexed its recently acquired enforcement muscles once again, forcing a label change for the long acting beta-2 agonist (LABA) class of drugs in an effort to reduce their use without another asthma controller medicine such as an inhaled corticosteroid.rnIn February, the agency issued a request for companies to change the labels themselves after the FDA's analyses of studies showed an increased risk of severe exacerbation of asthma symptoms leading to hospitalizations when LAB As are used alone.

机译：FDA再次展示了其最近获得的执行力，迫使长效β-2激动剂（LABA）类药物的标签更改，以减少在没有另一种哮喘控制药物（例如吸入皮质类固醇）的情况下减少使用。，FDA的研究分析表明，单独使用LAB As会严重加重哮喘症状，导致住院治疗的风险增加，FDA要求公司自行更改标签。

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《Washington Drug Letter》 |2010年第23期|P.3|共1页
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LaCrisha Butler;
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专利

1. FDA marketing v. first amendment: Washington legal foundation legal challenges to off-label policies may force unprecedented changes at FDA [J] . John Kamp, Daniel E.Troy, Elizabeth Alexander Food and Drug Law Journal . 1999,第4期

机译：FDA营销诉第一修正案：华盛顿法律基金会对标签外政策的法律挑战可能会迫使FDA发生前所未有的变化
2. CSPI says FDA's labeling enforcement report doesn't add up [J] . Zachary Richardson Food chemical news . 2006,第25期

机译：CSPI称FDA的标签执行报告未加总
3. FDA, BMS Change Videx Labeling To Add Warnings [J] . David Belian Washington Drug Letter . 2009,第26期

机译：FDA，BMS更改Videx标签以添加警告
4. LABAS-TS - A System for Assisting Labeling of Training Sets for Text Classification [C] . Alejandro Sierra-Munera, Alexandra Pomares-Quimbaya, Rafael Andres Gonzalez Rivera, International Joint Conference on Knowledge Discovery, Knowledge Engineering and Knowledge Management . 2017

机译：Labas-TS - 用于协助标记文本分类培训集的系统
5. Long distance functional coupling associated with EEG state changes: The examination of phase and amplitude synchrony of neural assemblies across hemispheres during REM and non -REM sleep onset. [D] . von Gizycki, Hans. 2008

机译：与EEG状态变化相关的远距离功能性耦合：在REM和非-REM睡眠发作期间，检查半球神经组件的相位和幅度同步。
6. Add-on LABA in a separate inhaler as asthma step-up therapy versus increased dose of ICS or ICS/LABA combination inhaler [O] . David B. Price, Gene Colice, Elliot Israel, 2016

机译：在单独的吸入器中添加LABA作为哮喘的逐步治疗与增加剂量的ICS或ICS / LABA组合吸入器
7. PRS40 THE IMPACT OF THE FDA'S RISK EVALUATION AND MITIGATION STRATEGIES (REMS) INITIATIVE ON PRESCRIPTION PATTERN FOR DRUGS APPROVED UNDER THE REMS PROGRAM AND RELEVANT NON-REMS COMPETITORS [O] . Horowicz-Mehler N, Sepulveda B, White C, 2010

机译：PRS40 FDA风险评估和缓解策略（REMS）对REMS计划和相关的非REMS竞争对手批准的药物处方类型的影响

FDA Forces LABA Drugmakers To Change Label, Add REMS

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