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Date:         Mon, 21 Oct 2002 13:21:50 +0200
Reply-To:     fvillamayor-research@ferrergrupo.com
Sender:       "SPSSX(r) Discussion" <SPSSX-L@LISTSERV.UGA.EDU>
From:         Frederic Villamayor <fvillamayor-research@ferrergrupo.com>
Subject:      Re: SPSS vs SAS
Content-Type: text/plain; charset="iso-8859-1"

Dear co-listers, On the following link http://www.fda.gov/cder/guidance/2867fnl.pdf there is the text for the "Guidance for Industry. Providing Regulatory Submissions in Electronic Format ? General considerations". On page 12, it

states that, currently, SAS System XPORT transport format (Version 5 SAS transport file) is the only format that FDA is able to accept. In the future, possibly other formats will be available (structured ASCII). Frederic Villamayor Departamento de Toxicología C.I.D.F. GRUPO FERRER

"R. Allan Reese" <R.A.Reese@gri.hull.ac.uk> Enviado por: "SPSSX(r) Discussion" <SPSSX-L@LISTSERV.UGA.EDU> 21.10.02 11:50 Por favor, responda a "R. Allan Reese"

Para: SPSSX-L@LISTSERV.UGA.EDU cc: Asunto: SPSS vs SAS

A summary circulated today on the ALLSTAT list contains several replies that the US FDA will accept pharmacological results ONLY when calculated using SAS and submitted as SAS files. I have an idea that SPSS Corp had refuted this in the past as an urban myth. If so, the company might wish to issue clarification on this list and on ALLSTAT.

Allstat archives can be accessed at www.jiscmail.ac.uk

R. Allan Reese Email: r.a.reese@gri.hull.ac.uk Associate Manager GRI Direct voice: +44 1482 466845 Graduate School Voice messages: +44 1482 466844 Hull University, Hull HU6 7RX, UK. Fax: +44 1482 466436 ====================================================================


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