[R] FDA and ICH Compliance of R

Thomas Lumley tlumley at u.washington.edu
Thu Nov 27 15:07:00 CET 2003

On Thu, 27 Nov 2003, Antonia Drugica wrote:

> I'm quite new to this medical stuff. But my associates told me that we are
> not free in choice of Statistical Software because the FDA has high
> standards concerning this topic. But if they would prefer a specific
> package (like SAS) that could mean, that this package vendourer could lay
> back and hold it's hand open for licence money.
> Is there any part of the ICH document referring to software packages? I
> really would use R for some tasks but therefor I need arguments...

As far as I can see, ICH has not said anything useful about software (the
most relevant things are about data management).


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