I wouldn't say FDA mandates or prefers SAS. You can use any software you want. I've sent SPLUS and R output to FDA.
SAS (as with other packages) is "21 CFR Part II" compliant".
And back in the day, the choices were SAS, SPSS, BMDP , eventually SPLUS (in the U.S.) and other less well known statistics packages. I used all of them.
Its entirely my own opinion, I think SAS succeeded in Pharma because of "productivity" tools - they had the best report writer ("data _null_"), and a batch script submission utility. SAS had a "data step" which was sort-of FORTRAN like, handy if you first learned to program in FORTRAN. They had a lot of other "features", say, a dozen or more types of data you could read in (binary, hex, etc.)
Before a report writer, there was a time when you wrote/typed values into a table, by hand, sent it to the Word processing group - and when it returned checked that the numbers were correctly typed. Made corrections as needed, including correcting your corrections, sent it back to word processing and repeated the loop. Eventually you got your table. And if you changed the analysis you updated the table, sent it back to word processing etc. With the 'data _null_" you could generate a "publication ready" table.
That noted, SPSS is thriving. IBM paid about $1.2 Billion to buy SPSS.
http://www-03.ibm.com/press/us/en/pressrelease/27936.wss I was recentlly in Fiji, and at the medical center in Suva Fiji they used SPSS. They commented that SAS was too expensive.
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Chris Barker, Ph.D.
President - San Francisco Bay Area Chapter of the American Statistical Association
www,barkerstats.com
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Original Message:
Sent: 08-22-2011 18:10
From: Winson Taam
Subject: Software Used for Consulting
It is sad that a regulatory agency "prefers" one commercial software over others.
I am glad that FDA does not mandate it.
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Winson Taam
The Boeing Company
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