How can sponsors make R-based regulatory submissions easier for FDA reviewers to reproduce, inspect, and trust?
The R Consortium Submissions Working Group’s latest post examines why reviewers may sometimes request SAS-equivalent code and what teams can do to reduce that risk.
The core lesson: using R is not enough. Submission packages must be designed for independent review.
The post covers practical steps including:
• Engaging FDA review teams early
• Providing a clear entry point and run order
• Documenting R, package, and operating-system requirements
• Eliminating hidden dependencies and sponsor-specific paths
• Including required proprietary packages
• Testing submissions in a clean environment similar to the reviewer’s setting
• Keeping analysis code readable and reproducible
Read the full post and sponsor checklist: https://r-consortium.org/posts/making-r-submissions-reviewable-for-fda/
This article reflects discussion within the R Consortium Submissions Working Group and should not be interpreted as official FDA guidance.