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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 involv
by HenrikB 4y ago
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]
[0] https://www.r-consortium.org/all-projects/isc-working-groups https://www.r-consortium.org/all-projects/isc-working-groups
[1] https://rconsortium.github.io/submissions-wg/ https://rconsortium.github.io/submissions-wg/
[2] https://www.r-consortium.org/blog/2021/12/08/successful-r-based-test-package-submitted-to-fda https://www.r-consortium.org/blog/2021/12/08/successful-r-ba...