This is a great post on another blog, the always-worthwhile Laszlo Letter, that details the top 12 issues for eCTD success as presented by a member of the FDA.
Reading the comments of that post details a similar listing of challenges from an EMEA presentation.
Although both are bit dated (the original post is from February 2007), they are still very much relevant.
The Laszlo Letter: Top 12 Issues for eCTD Success
18 May 2008
The Laszlo Letter: Top 12 Issues for eCTD Success
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