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The U.S. Food and Drug Administration (FDA) has released a new version of their eCTD validation criteria. The new version 2.1 is dated 12/20/2011 and contains significant changes compared to version 2.0 (as released in December 2010 - see our related News Article). According to the FDA this version is considered as the FINAL specifications for eCTD validation criteria, and contains the error conditions that have been incorporated into FDA's next version of validation software, which is currently undergoing testing.
The eCTD validation criteria 2.1 are available in PDF and Excel format; in addition a "Summary of changes" document is provided in Excel format which summaries the changes introduced since release of version 2.0.
All files are available for download from the FDA website.
Please note, that the afore-mentioned eCTD validation criteria 2.1 are not yet in force. FDA will provide 30 days notice prior to deploying the new eCTD validation software, at which time these new criteria will be effective.
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In addition the "Specification for Transmitting Electronic Submissions using eCTD Specifications" have been updated to version 1.4, dated 2011-12-28. The following changes have been introduced:
Submission media "Digital Linear Tape (DLT-IV)" and "Linear Tape Open (LTO)" will no longer be accepted starting January 2013. Instead, USB drives should be used for submissions > 45 GB in size. Detailed specifications for acceptable USB drives are given in the Transmission specification document. For submissions < 45 GB DVDs (up to 6 DVDs) should be used. In addition, e-mail addresses have been specified for CDER (ESUB@fda.hhs.gov) and CBER (ESUBPREP@fda.hhs.gov) which should be used to communicate any corresponding questions with the agency. Version 1.4 of the Transmission specification is available for download from the FDA website.
[Source: FDA website]
- Related News:
 US: FDA released Draft version 2.0 of eCTD validation criteria - 10.12.2010 18:27
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