[R] FDA and ICH Compliance of R

Spencer Graves spencer.graves at pdf.com
Thu Nov 27 12:24:02 CET 2003


      Have you tried "www.r-project.org" -> search -> "R site search"?  
This issue has been discussed in the past.  With luck, you may find 
something there that might help. 

      hope this helps.  spencer graves

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...
>
>
>
>
>  
>
>>"Antonia Drugica" <antoniamarija at net.hr> writes:
>>
>>    
>>
>>>Does anybody know if R is FDA or ICH (or EMEA...) compliant? AFAIK
>>>      
>>>
>S-Plus
>  
>
>>>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...
>>
>>best,
>>-tony
>>
>>-- 
>>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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>>
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>>    
>>
>
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