Venky recently wrote: >This shop recently moved from v6.12 to v8.2 and has >the validvarname option default to V6. I suspect that >many other pharmaceutical companies do the same. >This ensures that the transport datasets comply with >regulatory requirements.

Is FDA still requiring compatibility with SAS v6? And does anyone have a pointer to a discussion of current FDA data submission guidelines? (FDA's website guidance page has this on electronic submissions, requiring the v5 transport file format (which it says can be produced using the XPORT engine of V6 and later SAS): http://www.fda.gov/cder/guidance/2867fnl.pdf However, that document is more than three years old, and I wonder whether it does indeed still reflect current practice.

I will inquire of the FDA and report back to the list, but if anyone has any experience in the last year or so, please share it!

Steve Albert Director of Biostatistics Spectrum Pharmaceutical Research Corp. San Antonio, TX SAlbert@spectrumcro.com