Useful Websites
For Information About EDMS & Submission Publishing
- Structured Product Labeling (SPL) (Final)
- Study Data Tabulation Model
- FDA CDER & CBER Guidance Documents—Electronic Submissions (Draft)
- FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 1
- FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 2
- Acrobat & Plug-in Contacts
- Systems for e-Submissions
- Electronic Document Management Systems (EDMS)
- CTD/eCTD Information
- XML Vendors & Resources
- eCTD Overview
- Misc.
Structured Product Labeling (SPL) (Final)
- Providing Regulatory Submissions in Electronic Format – Content of Labeling. Posted 4/20/2005.
- Fall 2005 implementation
- Mandatory even if remainder of submission paper
- Applies to marketing application & post-marketing submissions
Uses HL7 Structured Product Labeling (SPL) specifications
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:
FDA CDER & CBER Guidance Documents—Electronic Submissions (Draft)
- Providing Regulatory Submissions in Electronic Format – General Considerations. Issued 10/2003.
- Updates PDF requirements
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
FDA CDER Guidance Documents—Electronic Submissions (Draft) – Part 2
- FDA Module 1 Specification. Updated version posted 8/13/2003.
- FDA Modules 2-5 Specification.
- Study Tagging File Specification. Updated version posted 8/13/2003.
- FDA eCTD Table of Contents Headings and Hierarchy. Updated version posted 8/28/2003.
Acrobat & Plug-in Contacts
- Adobe Systems, Inc.
- All things PDF:
- Appligent, Inc.
- Datafarm, Inc.
- DocMaestro Products
- Enfocus Software:
- Image Solutions, Inc.
- InfoData Systems, Inc.
- Quite Software:
Systems for e-Submissions
- Datafarm, Inc. – eCTDViewer & eCTD Builder
- Extedo, Inc. - eSubmission Management
- Generis – CARA
- GlobalSubmit, Inc.
- Image Solutions, Inc. – eCTDXPress
- Liquent, Inc. – CoreDossier & EZsubs
- Lorenz International LLC
- MedXview, Inc. – eCTDcomposer & eCTDauditor
- OpenText, Inc.
Many vendors emerging to address eCTD.
Electronic Document Management Systems (EDMS)
- EMC Software *
- First Consulting Group *
- QUMAS *
- FileNET, Inc.
- Hummingbird/PC DOCS
- MasterControl, Inc.
- Microsoft SharePoint Portal
- OpenText, Inc. *
- QUMAS *
*Integrated with submission publishing systems.
CTD/eCTD Information
All things CTD:
- European Agency for the Evaluation of Medicinal Products. ICH M4 Common Technical document for the Registration of Pharmaceuticals for Human Use – Organisation CTD.
- European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA eCTD Topic Group.
- DIA membership-only website with links to EU regulatory authorities.
- PhRMA eCTD web site
- European Commission Enterprise Directorate – General Pharmaceuticals and Cosmetics Unit. Presentation and format of the dossier CTD. July 2004. CTD in Europe
- CTD/eCTD in Japan
- http://aboutctd.com However, sponsored by Liquent.
- http://www.ectd.com However, sponsored by Sendar Menlha Group International.
- Health Canada
- Online Resource for Markup Language Technologies
- Virtual Regulatory Services Ltd. However, sponsored by a service bureau.
XML Vendors & Resources
- Altova, Inc. – Tools & Technologies for XML.
- Arbortext, Inc.
- IBM
- Microsoft
- O’Reilly International – Books on XML
- Organization for the Advancement of Structured Information Systems (OASIS)
- TIBCO Software Inc. TurboXML product
eCTD Overview
- Electronic Review System starting point on CDER web site
- Recent presentations by FDA, from April 22, 2005 Tutorial
Misc.
- www.expertbriefings.com - provider of FDA compliance Webinars
- www.laboratoryretriever.com - connects contract labs with firms needing contract lab/research assistance