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IND（新药临床研究)，有一段英文说明，不理解啥意思 已有1人参与
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Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. 发自小木虫Android客户端 |
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lyblyb1212
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原文：Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. 翻译：现行的联邦法律规定，在药品运输或分发到各州前，药品应当经批准允许上市。 由于申办者可能想将研究用药物运送到各州的临床研究者，因此必须寻求豁免该法律要求。 IND就是申办者从技术上获得FDA豁免的手段。 |
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