新药申请 NDA ; New Drug Application ; sNDA ; IND
简化新药申请 ANDA ; Abbreviated New Drug Application
简略新药申请 ANDA ; Abbreviated New Drug Application
简化的新药申请 ADNA Abbreviated New Drug Application ; ANDA
研究性新药申请 INDA
新药申请前 pre-NDA
试验用新药申请 INVESTIGATIONAL NEW DRUG APPLICATION
补充的新药申请 Supplemental NDAs
治疗性试验性新药申请 TREATMENT IND
格式之新药申请资料 NDA Checking List
当一家制药公司有一种新药时，它会向加拿大卫生部申请销售许可证。
When a pharmaceutical company has a new drug, it applies to Health Canada for a licence to sell it.
他查看了从1990年至2004年之间提交给FDA的884例新药申请。
He looked at 884 New Drug Applications (NDAs) submitted to the FDA for approval between 1990 and 2004.
金教授的假设是：比起管理局不熟悉的公司，一家公司对药物研发的贡献越多，它的新药申请获得通过的速度越快。
Mr Kim’s hypothesis was that a firm with a longer track record of contributing to drug development would have its NDAs approved faster than would a developer less well known to the FDA.
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