This process allows a company to file the sections of the New Drug Application (NDA) as they become available instead of filing all the sections at once.
这个过程允许公司提交的新药申请(NDA),因为它们变得可用,而不是提出在一旦所有的部分章节。
The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee act (PDUFA) target action date for the Company's NDA of January 23, 2008.
食品与药品管理局已经接受该公司的新药申请并将文件归档,而且还组织了处方药物使用权行动,活动目标是将公司新药注册日期定在2008年一月二十三日。
The FDA has accepted the Company's NDA for filing and has set a Prescription Drug User Fee act (PDUFA) target action date for the Company's NDA of January 23, 2008.
食品与药品管理局已经接受该公司的新药申请并将文件归档,而且还组织了处方药物使用权行动,活动目标是将公司新药注册日期定在2008年一月二十三日。
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