Can anyone provide chapter and verse on this "FDA and SAS" question?
The only guideline I can find on www.fda.gov which seems really
relevant is "Format and Content of the Clinical and Statistical Sections
of an Application" ( http://www.fda.gov/cder/guidance/statnda.pdf ),
in which the only relevant statement is
"Generally, it is recommended that SAS Type III or equivalent
analyses be provided in addition to any other analyses."
This document dates from July 1988, posted on the FDA website
May 1997, and still there. The "or equivalent" supports Tang's
view (below); and while there are preferences for formats of
data files in submissions this has nothing to do with what
software you use to do the analysis itself, as such.
Best wishes to all,
Ted.
On 23-Oct-02 Tang, Chi wrote:
> Dear Allstat Members,
>
> Recently some questions have surfaced about whether or not SPSS can be
> used to make submissions to the FDA or whether you have to use SAS.
> This response is not an endorsement of SPSS but rather the true facts
> of what you can and can't do. Basically the answer is "no", it is not
> essential to use SAS in order to make submissions to the FDA. Many
> stats packages can be used if they contain certain analyses and that is
> all the FDA asks for.
>
> In the past there was a line in the FDA Guidelines that said that the
> FDA wanted a certain type of measure in 'SAS or similar' format and
> people took that as an endorsement of SAS. The FDA agreed to remove the
> reference to SAS because it was an issue in terms of restraint of
> trade. FDA guidelines still require certain analyses to be done but the
> document does not require one to use SAS to produce those analyses.
> (For example, some situations might require the use of Type IV sums of
> squares, which SPSS and other stats packages will also produce.)
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Date: 23-Oct-02 Time: 11:49:35
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