What is ESG (Electronic Submission Gateway)? The ESG has been setup by FDA for transfer of regulatory information in the form of eCTD, SPL, eDMF, etc.. The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:
Study tagging file (STF) is an xml which contains the group of files for a particular study. Study tagging files are required and applicable in US. Study tagging files applies to only module 4 and module 5 of eCTD.