eCTD and the eNDA

7/8/2003


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Table of Contents

eCTD and the eNDA

Your Providing an Electronic Application

Paperless NDA

Paperless NDA as CTD

eCTD

eCTD Differences

eCTD Differences

eCTD Differences

eCTD Differences

eCTD Differences

Vendors

FDA

Why Move to eCTD?

Same System for All

Incorporate by Reference (Almost)

Automated Research

Remember When

Next Horizon

Demonstration

End

 Author: CDER/USER

Home Page: http://www.fda.gov/cder/regulatory/ersr/DIA2003.htm

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