Learnings from the First R-Based Submission to FDA by Novo Nordisk

Novo Nordisk stands as a trailblazer in R-based submissions to the FDA, having recently completed the inaugural submission in this statistical programming language to regulatory authorities. This milestone was achieved at the close of 2021, encompassing the inclusion of SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets, programs, …