Creating Documents and eCTD Specifications

7/8/2003


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Table of Contents

Creating Documents and eCTD Specifications

Benefit of Electronic Submissions Using eCTD Specifications

PPT Slide

Computer Readable Document Information

Document Granularity Subject Matter

Document Subject Matter

Specific Documents Study Reports

Document Granularity Submission

Changes from Current Electronic Submission to eCTD Specification

Other Topics

Referencing Previously Submitted Documents

Referencing Previously Submitted Documents

Bookmarks and Hypertext Links

Scanned Documents

More Information

Author: LEVINR

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

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