USA – FDA updates guide for e-submission of trial data

A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.

The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework laid out in a related draft guidanceStandardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions…