There are working groups under the R Consortium umbrella that work on FDA-related tasks with a focus on R [0]. Folks from the pharma industry and FDA are involved.
One of the working groups is dedicated toward submissions: R Submissions Working Group [1]. They recently announced: "The R Consortium is happy to announce that on Nov 22nd, 2021, the R Submissions Working Group successfully submitted an R-based test submission package through the FDA eCTD gateway! The submission package has been received by the FDA staff who were able to reproduce the numerical results." [2]