For Industry

Statistical Software Clarifying Statement

FDA does not require use of any specific software for statistical analyses, and statistical software is not explicitly discussed in Title 21 of the Code of Federal Regulations [e.g. in 21CFR part 11].  However, the software package(s) used for statistical analyses should be fully documented in the submission, including version and build identification. 

 
As noted in the FDA guidance, E9 Statistical Principles for Clinical Trials (available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm), “The computer software used for data management and statistical analysis should be reliable, and documentation of appropriate software testing procedures should be available.”  Sponsors are encouraged to consult with FDA review teams and especially with FDA statisticians regarding the choice and suitability of statistical software packages at an early stage in the product development process. 

Page Last Updated: 05/06/2015
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