Re: [R] Using R in a university course: dealing with proposal comments

From: S Ellison <>
Date: Tue, 12 Feb 2008 17:22:07 +0000

>>> "Stas Kolenikov" <> 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

This email and any attachments are confidential. Any use...{{dropped:8}} mailing list PLEASE do read the posting guide and provide commented, minimal, self-contained, reproducible code. Received on Tue 12 Feb 2008 - 17:32:42 GMT

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