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dilemmaly

金虫 (正式写手)

[求助] 划线部分怎么翻译什么意思?谢谢!已有1人参与

After submission of the IND, the sponsor must delay the use of the drug in human subjects for not less than 30 days from the date the FDA acknowledges the receipt of the application. An IND automatically goes into effect following this period unless the FDA notifies the sponsor that as a result of its review of the submission. it is waiving the period and the sponsor may initiate the study early or the investigation is being placed on a clinical hold.
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sqlg888

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【答案】应助回帖

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dilemmaly(空位代发): 金币+3, 感谢应助 2016-06-24 14:55:04
the investigation is being placed on a clinical hold————————就是说:
The US FDA has placed a clinical hold on an investigational the drug for the treatment,对这个药的临床观察要做,请申请者(赞助人)尽早准备,启动实验。
2楼2016-06-24 14:35:15
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