The U.S. Food and Drug Administration (FDA) has published the draft "eCTD Backbone Files Specification for Module 1 Version 2.0" together with the updated...[more]
The Belgian Federal Agency for Medicines and Health Products (FAGG) has revoke the previously released version v.2.9.b (see our related News Article from September) of the...[more]
Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. In addition to the announcement in May this year (see our previous News...[more]
Update! Please note that the information below is outdated. Meanwhile, the version v.2.9.b of the NeeS checker has been revoked by the FAGG. See our related News Article from...[more]
The U.S. Food and Drug Administration (FDA) has published the draft PDUFA V (Prescription Drug User Fee Act) "Reauthorization Performances Goals and Procedures Fiscal Years...[more]
The EU Telematics Implementation Group - electronic submissions (TIGes) has released a new version 2.0 of the "TIGes Harmonised Guidance for eCTD Submissions in the EU"...[more]
The Belgian Federal Agency for Medicines and Health Products (FAHMP) has released a new version of their national "eSubmission Guidelines" document, version 2.10 which...[more]
ectdexperts
25.01.2012, 22:30 @kathie_clark: FDA re-issues PDF Spec V3.1 to clarifiy language on acceptable PDF versions for documents, add page numbers #ectd htt ...
