13:15 Jul 16, 2016 |
English to Chinese translations [PRO] Medical - Medical: Pharmaceuticals / Assay approval for a vaccine | |||||||
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| Selected response from: jyuan_us United States Local time: 01:22 | ||||||
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Summary of answers provided | ||||
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4 +2 | 对于先前的批准的补充 |
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4 +1 | 批准前申报/批准前申请补充 |
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3 | 预先批准所需之补充材料 |
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prior approval supplement (pas) 批准前申报/批准前申请补充 Explanation: FDA公布已批准变更的可比性方案应用指南草案 - 360Doc个人图书馆 www.360doc.com/content/16/0508/06/723238_557181313.shtml Translate this page May 8, 2016 - ... application or prior approval supplement (PAS) will, in many cases, ... 在原始申报或批准前申报(PAS)中使用CP,在许多情形下,会有助于之后 ... FDA行业指南 201403:应在年报中记载的CMC已批准生产变更(一)_ ... blog.sina.com.cn/s/blog_4298a2c80101hzmo.html Translate this page Jun 6, 2014 - 附录B提供了在年报中应记载的轻微变更的例子,之前是包括在FDA的放大 ... is distributed (also known as a prior approval supplement (PAS)). 生命科学与制药博客| 汤森路透 ip-science.thomsonreuters.com.cn/lscn/ls-blog/20160403.shtml Translate this page Apr 3, 2016 - 美国卫生与公共服务部(U.S. Health and Human Services,HHS)前 .... 年,之前批准申请的补充(Prior Approval Supplements,PAS)和CR的数量 ... |
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prior approval supplement (pas) 对于先前的批准的补充 Explanation: 这样断句:“prior approval” + supplement= prior approval‘s supplement = A supplement TO A prior approval = 对于先前的批准的补充 也就是在有新资料出现时向FDA提交补充件 -------------------------------------------------- Note added at 16 hrs (2016-07-17 05:31:26 GMT) -------------------------------------------------- 网上的去许多译文(包括大药商的译文)的错误都是由于译者把PRIOR等同于PRE.两者看似类似,意思差之千里。 PRIOR = Previous, not = Before something |
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