Useful Websites

For Information About EDMS & Submission Publishing



Structured Product Labeling (SPL) (Final)

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Study Data Tabulation Model

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FDA CDER & CBER Guidance Documents—Electronic Submissions (Draft)

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FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 1

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FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 2

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Acrobat & Plug-in Contacts

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Systems for e-Submissions

Many vendors emerging to address eCTD.

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Electronic Document Management Systems (EDMS)

*Integrated with submission publishing systems.

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CTD/eCTD Information

All things CTD:

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XML Vendors & Resources

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eCTD Overview

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Misc.

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