Table of Contents
Electronic Submissions to the FDA
Overview
Regulations for Electronic Submissions
Public Docket 92s-0251
Number of Electronic NDA Submissions
Cumulative Electronic NDAs
Electronic NDA Percentages
Electronic Submission Guidance
Current Electronic Submission Technology
Current Electronic Submission Technology
eNDA to eCTD Transition
eNDA to eCTD Change
eNDA to eCTD Remain the Same
Timeline to eCTD To Do List
eNDA/CTD Interim Solution Changes
eNDA/CTD Interim Solution Remain the Same
eNDA/CTD Interim Solution Draft Guidance
Information
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Author:
Randy Levin, M.D.
Associate Director for Information Management
Center for Drug Evaluation and Research,
Food and Drug Administration, USA
Home Page: http://www.fda.gov/cder/regulatory/ersr/default.htm
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