field copy certicification

zyul163

请问M1模块中的field copy certicification是什么意思？

blueangelhui

这是FDA申报中需要的一个声明吧，应该是说，现场审计时的现场资料与你申报提交的资料一致的一个声明。详见下文：
The NDA must include a certification statement noting that the field copy, submitted to the local FDA office, is a true copy of the CMCs section that was submitted in the archival and review copies of the application. However, FDA district offices have access to documents submitted in electronic format. Therefore, when sending submissions in electronic format, any duplicate documentation to the FDA Office of Regulatory Affairs District Office must be provided.14 To meet the requirements of the regulation, a letter certifying that the electronic CMC section has been submitted should be provided to the Office of Regulatory Affairs District Office and a letter certifying that the letters were submitted should be included in the NDA.

7Dmnz2ialk

blueangelhui 发表于 2018-3-7 12:28
这是FDA申报中需要的一个声明吧，应该是说，现场审计时的现场资料与你申报提交的资料一致的一个声明。详见 ...

请问这句话出处是哪里呀，谢谢，以及
Three copies of the NDA are required: An archival copy, a review copy, and a field copy.
这里的review copy是指什么？是指通过eCTD系统递交的文件吗