问题: For sterile drug products subject to a new or abbr
For sterile drug products subject to a new or abbreviated drug application (NDA or ANDA), this guidance document should be read in conjunction with the 1994 guidance on the content of sterile drug applications请哪位高手翻译一下。
解答:
For sterile drug products subject to a new or abbreviated drug application (NDA or ANDA), this guidance document should be read in conjunction with the 1994 guidance on the content of sterile drug applications
对于需要按照新的或者简要药品申报程序(NDA或者ANDA)申报的灭菌药品,本指导文件应该和1994年关于灭菌药品申报的指导文件结合起来阅读。
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