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Useful Websites |
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For Information About EDMS & Submission Publishing
Structured Product Labeling (SPL) (Final) Top Study Data Tabulation Model - FDA Public Meeting February 1, 2005
- Steps being taken by FDA to require submission in electronic format:
- Stability datasets
- Animal datasets
- Human datasets
- Analysis-ready datasets
- Profound change from business as usual:
- Agency
- Sponsors
- CROs
- Vendors
- Additional resources:
Top FDA CDER & CBER Guidance Documents—Electronic Submissions (Draft) Top FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 1 -
Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Applications and Related Submissions. Posted 8/28/2003 Top FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 2 Top Acrobat & Plug-in Contacts Top Systems for e-Submissions Many vendors emerging to address eCTD. Top Electronic Document Management Systems (EDMS) *Integrated with submission publishing systems. Top CTD/eCTD Information All things CTD: Top XML Vendors & Resources Top eCTD Overview Top |
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