Name of define xml file

Pinnacle 21 Support Define.xml
1

Hi Heidi,

Name of file submitted to FDA must be “define.xml”.

This is a new eCTD Rejection rule.

Regards,

Sergiy.

2

Thank you for the prompt reply, Sergiy

3

Hi,

Using Pinnacle 21 Community to create a define XML the resulting define file is named “-<date/time>.XML”.

Is it allowed to submit the define file named like this to FDA? Or is any specific file name required for the “define.XML” file?

Thanks and regards

Heidi