FDA and SAS Technology

The Food and Drug Administration (FDA) expects clinical and non-clinical data submitted as part of an NDA or BLA to be in SAS v5 transport format, described in FDA's "Study Data Specification." 

Additionally, the links below provide information on using the SAS XPORT transport format to submit data sets to the FDA. Specifications for the XPORT format are provided in TS-140 so that it is not necessary to use SAS software to translate data sets to/from this format.

• FDA Standards for Electronic Submissions

• Q&A: The SAS XPORT Transport Format as an FDA Standard for Data Sets

• Code for Processing Data Sets to/from the Transport Format

• The Record layout of a Data Set in SAS XPORT Transport Format (TS-140) 

• SAS System Viewer Included in FDA Guidance Recommendations

• The Electronic Records; Electronic Signature Rule
  

To request more information, please contact Joseph.Boland@sas.com.