Another US/EU Regulatory Split

Ian Schofield

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Another US/EU Regulatory Split

机译：美国/欧盟的另一项监管分歧

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It's common knowledge that the US and European Union drug regulators often reach different conclusions as to whether a pharmaceutical product should be approved, withdrawn or restricted. Those differences have been thrown into even sharper relief by the US Food and Drug Administration's decision to approve Sandoz's generic version of sanofi-aventis's low molecular weight heparin, Lovenox (enoxaparin sodium).

机译：众所周知，美国和欧盟的药品监管机构通常就药品应被批准，撤销还是受限制而得出不同的结论。美国食品药品监督管理局（FDA）批准山度士（Sandoz）的赛诺菲-安万特（sanofi-aventis）低分子肝素Lovenox（依诺肝素钠）的仿制药的决定，使这些分歧更加明显。

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《The regulatory affairs journal: Pharma》 |2010年第8期|共2页
作者
Ian Schofield;
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正文语种 eng
中图分类药学;
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1. Another US/EU Regulatory Split [J] . Ian Schofield The regulatory affairs journal: Pharma . 2010,第8期

机译：美国/欧盟的另一项监管分歧
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机译：Dync1i1基因座的监管活动的外显子缺失与分割/分裂脚畸形有关：阵列CGH筛选134无关的家庭
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6. Deletions of exons with regulatory activity at the DYNC1I1 locus are associated with split-hand/split-foot malformation: array CGH screening of 134 unrelated families [O] . Naeimeh Tayebi, Aleksander Jamsheer, Ricarda Flöttmann, 2014

机译：DYNC1I1基因座处具有调节活性的外显子的缺失与手裂/足裂畸形相关：对134个无关家庭的阵列CGH筛查
7. Deletions of exons with regulatory activity at the DYNC1I1 locus are associated with split-hand/split-foot malformation: array CGH screening of 134 unrelated families [O] . Tayebi Naeimeh, Jamsheer Aleksander, Flöttmann Ricarda, 2015

机译：DYNC1I1基因座处具有调节活性的外显子的缺失与手裂/足裂畸形相关：对134个无关家庭的阵列CGH筛查

Another US/EU Regulatory Split

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