eCTD Cross Application Links

A little while ago, a client asked me about referencing documents submitted in one application from another application. Her question was in the context of an IND and an NDA, both submitted in eCTD format – did she have to re-submit documents in her NDA that had already been submitted in her IND? The ICH guidance is basically silent on this subject, although the structure does not specifically prohibit any valid relative link....

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Submitting Documents with Track Changes

Recently, I have come across several instances where applicants or regulators have discussed submitting documents with tracked changes. Clearly, there is some guidance for this in the area of EU and US labeling, but this was the first that I had heard of it potentially being done elsewhere in a dossier. The first was at DIA, where Norman Schuff of the FDA recommended submitting Module 3 replacement documents with tracked changes...

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Advantages of Electronic Submissions vs. Paper

I attended a session at the DIA annual meeting where the regulators spoke about the status of eCTD in their regions. I’ll give some updates from EU and Japan in my next post; today’s post focuses on FDA updates. Gary Gensinger gave the US eSubmission update. The most interesting point that Gary made was in the “myth busting” department. Gary told us “There is no advantage to submitting in paper over...

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