[R] FDA and ICH Compliance of R

Antonia Drugica antoniamarija at net.hr
Thu Nov 27 07:48:02 CET 2003

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...

>"Antonia Drugica" <antoniamarija at net.hr> writes:
>> Does anybody know if R is FDA or ICH (or EMEA...) compliant? AFAIK
>> is but that means nothing...
>As Thomas pointed out, that does mean nothing -- there was a group of
>folks discussing what might be done to help, earlier this year, but
>then everyone got busy...
>rossini at u.washington.edu            http://www.analytics.washington.edu/ 
>Biomedical and Health Informatics   University of Washington
>Biostatistics, SCHARP/HVTN          Fred Hutchinson Cancer Research Center
>UW (Tu/Th/F): 206-616-7630 FAX=206-543-3461 | Voicemail is unreliable
>FHCRC  (M/W): 206-667-7025 FAX=206-667-4812 | use Email
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>R-help at stat.math.ethz.ch mailing list

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