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Date:         Thu, 24 Oct 2002 16:32:25 -0500
Reply-To:     "Weeks, Kyle" <kweeks@spss.com>
Sender:       "SPSSX(r) Discussion" <SPSSX-L@LISTSERV.UGA.EDU>
From:         "Weeks, Kyle" <kweeks@spss.com>
Subject:      SPSS and the FDA
Content-Type: text/plain; charset="US-ASCII"

> Recently some questions have surfaced about whether or not SPSS can be used to make submissions to the FDA. The answer is yes. > 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 will also produce.) > The FDA page referenced recently in a list discussion (http://www.fda.gov/cder/guidance/2867fnl.pdf) refers specifically to electronic submissions and archiving of data; it has nothing to do with the statistical analyses performed. However, when submitting applications entirely by electronic means, the FDA requires that the data be submitted as a SAS Transport file. This capability was added to SPSS for release 11.5. > To further clarify the fact that different packages may be used to analyze data for FDA submissions, electronic or paper, note that after stating that only SAS Transport files may be electronically archived, the document referenced above explicitly states (Section IV.A.2): "We use a variety of software tools to analyze the datasets." > Regards. > > Kyle Weeks, Ph.D. > Senior Product Manager, Product Management and Marketing > kweeks@spss.com > SPSS Business Intelligence division > Phone: 1.312.651.3645 / Fax: 1.312.651.3690 > SPSS Inc., 233 S. Wacker, 11th Floor, Chicago, IL 60606 USA > www.spss.com > > SPSS Business Intelligence division helps people solve business problems using statistics and data mining. >


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