FDA acceptance on software R [Software]
Dear Nirali,
I myself have no sure experience since seldom worked for an FDA submission and always stuck with SAS. Additional said sure is a term which should be avoided in the context of regulatory acceptance
. Have a look at ElMaestros signature.
But have a look at this blog "Analyzing clinical trial data with R" or this blog and the documents linked there to get some valuable informations about that topic from an R-viewpoint.
See also "Using R: Perspectives of a FDA Statistical RevieweR" to get the key message "The Food and Drug Administration does not endorse or require use of any specific software".
Hope this helps.
I myself have no sure experience since seldom worked for an FDA submission and always stuck with SAS. Additional said sure is a term which should be avoided in the context of regulatory acceptance

But have a look at this blog "Analyzing clinical trial data with R" or this blog and the documents linked there to get some valuable informations about that topic from an R-viewpoint.
See also "Using R: Perspectives of a FDA Statistical RevieweR" to get the key message "The Food and Drug Administration does not endorse or require use of any specific software".
Hope this helps.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- FDA acceptance on software R Nirali 2013-08-16 08:03
- FDA acceptance on software Rd_labes 2013-08-16 08:27
- FDA acceptance on software R Nirali 2013-08-16 08:35
- FDA acceptance on software Rd_labes 2013-08-16 08:27