Online Program

R for Regulatory Submissions: Challenges and Approaches (302474)

*Paul Schuette, US Food and Drug Administration 

Keywords: R, Statistical Software, Regulatory Submissions

As stated in FDA’s 2015 Statistical Software Clarifying Statement, FDA does not require the use a specific statistical software package for regulatory submissions. This talk will address some of the challenges and potential solutions for using R in regulatory submissions. Additionally, we shall briefly discuss initiatives to support R submissions such as those of the R Validation Hub, R Consortium efforts and TransCelerate’s recommendations for “Modernization of Statistical Analytics.”