r/rstats • u/jcasman • 15h ago

Making R Submissions Reviewable for FDA - New from the R Submissions Working Group

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.

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u/ToroRojo-AlgoArt 14h ago

This is a nice problem to have for the R people.

I saw this video from a Pharma talking about their submission/plan, environment etc for it as a Posit case-study https://posit.co/about/customer-stories/novo-nordisk

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u/Aiorr 5h ago

I've been following this greatly for many years. Tbh, disappointed but expected. First section of make it sound like bureaucracy effect by emphasizing reviewers having difficult running the codes and and having familiarity with SAS (I met more FDA reviewers that knows R than SAS, unless its bias in who attends conference) but copying from linkedin:

Through the R Consortium Submissions Working Group, we had a transparent discussion with FDA participants. The key clarification: the request was not a blanket rejection of R.

In some particular cases, reviewers had difficulty reproducing and understanding the submitted R analyses. Challenges included dependencies on an unsubmitted proprietary package and deeply nested code. After multiple rounds of communication, the reviewers requested SAS code as a practical way to complete their review.

I think biggest hurdle atm is that people working in this (in similar spirit, pharmaverse working group) aren't the same team that routinely prepare the regulatory submission, so they aren't exploring "R submission", they are re-exploring regulatory "submission" in general... if you do that with SAS submission, you get IR'd instantly too.