FDA: eCTD Validation Criteria & Transmitting Electronic Submissions – Updates

 

FDA New Validation Criteria Version 2.1 – Update 

FDA has posted the new eCTD validation criteria document version 2.1 on 20^th December 2011. This document status is final now. FDA has planned to incorporate the validation sets in the next version of the validation software, currently the software is under testing.  

FDA will provide 30 days notice prior to deploying the new eCTD validation software, at which time these new criteria will be effective.  Notice will be provided soon through FDA eSubmission web page.

For our convenience FDA has posted the following documents 

• Specifications for eCTD Validation Criteria Version 2.1 - PDF version (12/20/2011)
• Specifications for eCTD Validation Criteria Version 2.1 - XLS version (12/20/2011)
• Summary of changes since Version 2.0 - XLS version (12/20/2011)

For our convenience, an XLS version of this document has posted in addition to the PDF version.  We can find summary of changes since version 2.0 XLS document.  

To find more information and to download the above mentioned document please use below mentioned FDA weblink

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm163181.htm

Specification for Transmitting Electronic Submissions using eCTD Specifications – Update

FDA has updated the Specification for Transmitting Electronic Submissions using eCTD Specifications on 28^th December 2011. The current version of this document is 1.4.

The following information FDA has updated in the current version of this document.

·         Added information regarding USB media format

·         Added retirement date for Tape options

·         Added email address for Questions/Communication with Centers

According to the updated document FDA will not accept submission media "Digital Linear Tape (DLT-IV)" and "Linear Tape Open (LTO)" starting January 2013. Up to 45GB submission FDA asked to submit in DVD’s (1 to 6 DVD’s). If the submission is more than 45 GB in size sponsor can use USB.  Sponsors shouldn’t submit USB Drive if their submission size is under 45GB.

Sponsor can direct their questions by using the following mail id’s

CDER - ESUB@fda.hhs.gov

CBER - ESUBPREP@fda.hhs.gov

To more information and to download the updated guidance please use the below mentioned FDA weblink

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163567.pdf