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...gov/cder/Offices/Biostatistics/Bell.pdf In 2007, during an FDA committee meeting reviewing the safety profile of Avandia (Rosiglitazone), the internal FDA meta-analysis performed by Joy Mele, the FDA statistician, was done using R. A copy of this presentation is available here: http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4308s1-05-fda-mele.ppt Given the high profile nature of drug safety issues today, that R was used for this analysis by the FDA itself speaks volumes. Also in 2007, at the annual R user meeting at Iowa State University, I had the pleasure and privilege of Chairing a sessi...

Dear All, discussing with a statistician of a pharmaceutical company I received this answer about the statistical package that I have planned to use: As R is not a validated software package, we would like to ask if it would rather be possible for you to use SAS, SPSS or another approved statistical software system. Could someone suggest me a 'polite' answer? TIA Giovanni -- dr.