Using R in a university course: dealing with proposal comments

"Stas Kolenikov" <skolenik at gmail.com> 11/02/2008 18:54 >>>

I would think the FDA regulations could go as far as
specific SAS syntax, or at least to specify SAS PROCs to be used. 

This is unnecessary caution. FDA (like the MHRA in the UK, where I come
from) should not endorse a single supplier, even by implication, and
certainly not in the regulations themselves.

The most you will get is examples in FDA-endorsed guidance documents
that happen to use a particular package.

Most regulatory agencies take the view that it is for the applicant to
demonstrate the validity of their methods; if they can do that, the
regulatory agencies pass the application. The only problem is that many
regulators are familiar with particular software, which then gets an
easier ride than "unfamiliar" applications. That tends to slow uptake of
new packages.

Steve E


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