Table of Contents
eCTD Processing
Overview
Submissions 101
Submissions 101
eCTD Guidance
eCTD Changes
What doesn’t change
Implementing the Guidance
eCTD Related Tools
Submission Processing Tool
Submission Review Tools
Availability of Tools For Industry
Future eSubmission Direction
Resources for the Reviewer
References
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Author: Gary M Gensinger
Home Page: http://www.fda.gov/cder/regulatory/ersr/DIA2003.htm
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