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
====================================================================