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When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.
The current FDA specifications governing grouped submissions state that Application Type and Submission Type have to agree. Accordingly, you would have no trouble grouping NDA labeling supplements.
A grouped submission eliminates the need to submit multiple, identical submissions to different applications. For example, a manufacturing part change might impact a dozen applications. In the age of grouped submissions, a new sequence would be created to note the part change, and that sequence would then point to all other applications affected.
The M1 initiative, specifically the updated guidelines for Ad Promo submissions, is an example of the FDA gently nudging sponsors to adopt practices that will benefit industry as a whole. The draft guidance on the Ad Promo topic states “the Agency is currently able to process, review, and archive electronic formats in eCTD and firms are strongly encouraged to make such submissions electronically.”