Industries / Government

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.

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