When submitting analyses to FDA how does using R affect issues of software validation?

I have worked on clinical trials in FDA submissions for many years. I use SAS almost exclusively. Recently I discussed a consulting job I had to bootstrap a Deming regression. Bootstrapping is much more easily done in R I think and several experts have suggested ways that I can do this in R. Since this is going into a resubmission to the FDA for my client I am concerned as to whether software validation might become an issue. I hear that R is gaining acceptance with the FDA and experts tell me that traceability which is an attractive feature with SAS can be dealt with easily in R as well.

My client did the original Deming regression with a package that I am not familiar with and validation was not an issue with the original submission. I want to help without adding any new headaches for them.

Can the R experts here give me some guidance? If it will help I can mention some of the programming options that were suggested?


We have done tons of submission to the FDA with R.
The Agency do not prefer a software versus the other.

Source : Link , Question Author : Michael R. Chernick , Answer Author : Samer

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