在此次撤市之后，麦罗塔将来在美国的任何一种使用都将需要向FDA提交一项研究性新药申请。
Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.
如适用，在新药申请中，交叉验证研究数据的信息。
In NDA submissions, information about cross-validation study data, if applicable.
本研究基本完成了国家一类新药制剂学部分的临床前资料，处方已申请专利。
The preclinical study of it as lnd category new drug of China have been finished basically and the formulation has been patented.
血液制造商开始根据FDA的研究性新药(IND)申请程序执行核酸检测(NAAT)。
The Blood manufacturing community began implementation of Nucleic Acid Amplification Testing (NAAT) under the FDA's Investigational New Drug (IND) application process.
为化合物的研究中的新药物申请(IND)。
Investigational New Drug Application (IND) for the compound.
该新药申请文件包含三期临床的三大关键研究数据，所有这些都符合主要疗效终点。
The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints.
该新药申请文件包含三期临床的三大关键研究数据，所有这些都符合主要疗效终点。
The NDA file contains data from three large pivotal phase 3 studies, all of which met their co-primary efficacy endpoints.
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