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2009 Jan 11
2
R, clinical trials and the FDA
...a session with a presentation entitled Times 'R' A Changing: FDA Perspectives on Use of "Open Source". A copy of this presentation is available here: http://www.fda.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...