The US FDA submission standards are based on the worldwide accepted eCTD format. Documentation requirements and the modular structure of the FDA eCTD are almost the same as for a European eCTD.

However, the FDA has some specific requirements that lead to a specific submission structure.
eCTDmanager supports the US FDA submission structure DTDs 3.3 and 2.01.
The us-regional.xml file controls the information within Module 1, in accordance with the eCTD backbone files specification for Module 1. The basic structure is the same as within EU eCTD submissions, but there are some fundamental differences in the level of detail that needs to be included with each submission.

eCTDmanager can handle "Structured Product Labeling" (SPL) information, which allows to add the SPL XML file and all related files as separate documents to the respective specific sections in module 1.
For non-clinical and clinical studies, the use of "Study Tagging Files" (STF) is obligatory in US-FDA submissions. STFs contain additional information in form of machine-readable metadata to studies and study data. They are enhancing the information provided by the eCTD backbone file.
A document which has already been submitted within an application or submission does not need to be submitted in another application or submission again. You can use Cross Application References / Hyperlinks / Bookmarks instead.
"US grouped submissions" allow applicants to submit information that applies identically to multiple applications in one single submission. Grouped Submissions eliminate the need to submit multiple, identical submissions to different applications. Before you are able to create for example a dossier for US FDA, your administrator should adjust some settings in the main configuration file of eCTDmanager. Also regional attribute value lists must be initially imported into eCTDmanager.
We stronlgy recommend to complete the eCTDmanager Basic Training part 1-3. This eLearning course does not recapitulate basic training content!

This course was re-designed in Q3 2024, the overall duration is 83 minutes.