In December 2014, the FDA published the long-awaited binding guidance documents regarding submission of study data in standardized formats, which are available on the FDA Study Data Standards Resources page.  

 

The Guidance on Providing Regulatory Submissions in Electronic Format requires submissions be submitted in an electronic format specified by the FDA beginning 24 months from the issuance of this document.

 

The Guidance on Standardized Study Data states:

"After the publication of this guidance, all studies with a start date 24 months after the publication date must use the appropriate FDA-supported standards, formats, and terminologies specified in the Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions.”

 

The current FDA Data Standards Catalog specifies use of the CDISC SDTM, SEND, ADaM and Define-XML standards as well as CDISC Controlled Terminology. 

 

The final Study Data Technical Conformance Guide has also now been posted by FDA.  This document, which includes changes from the draft published last February in response to industry comments, provides specifies specific rules for using CDISC standards on submissions to FDA CDER and CBER.