agree with Frank. as far as I've known, FDA doesn't encourage or discourage the usage of software.
On 6/8/07, Frank E Harrell Jr <[EMAIL PROTECTED]> wrote: > Giovanni Parrinello wrote: > > 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 > > > > Search the archives and you'll find a LOT of responses. > > Briefly, in my view there are no requirements, just some pharma > companies that think there are. FDA is required to accepted all > submissions, and they get some where only Excel was used, or Minitab, > and lots more. There is a session on this at the upcoming R > International Users Meeting in Iowa in August. The session will include > dicussions of federal regulation compliance for R, for those users who > feel that such compliance is actually needed. > > Frank > > -- > Frank E Harrell Jr Professor and Chair School of Medicine > Department of Biostatistics Vanderbilt University > > ______________________________________________ > [email protected] mailing list > https://stat.ethz.ch/mailman/listinfo/r-help > PLEASE do read the posting guide http://www.R-project.org/posting-guide.html > and provide commented, minimal, self-contained, reproducible code. > -- WenSui Liu A lousy statistician who happens to know a little programming (http://spaces.msn.com/statcompute/blog) ______________________________________________ [email protected] mailing list https://stat.ethz.ch/mailman/listinfo/r-help PLEASE do read the posting guide http://www.R-project.org/posting-guide.html and provide commented, minimal, self-contained, reproducible code.
