The R Consortium is pleased to announce that on Sept 27, 2023, the R Submissions Working Group successfully completed the follow-up to the pilot 2 R shiny based submission and received FDA CDER response letter!
To our knowledge, this is the first publicly available submission package that includes a Shiny component.
The full response letter can be found at: https://github.com/RConsortium/submissions-wg/blob/0f1dc5c30985d413f75d196c2b6caa96231b26ee/_Documents/Summary_R_Pilot2_Submission%2027SEP2023.pdf All submission materials can be found at: https://github.com/RConsortium/submissions-pilot2-to-fda
The objective of the R Consortium R submission Pilot 2 Project is to test the concept that a Shiny application created with the R-language can be bundled into a submission package and transferred successfully to FDA reviewers.
The initial submission was submitted through the eCTD gateway on Nov 18, 2022. FDA verbal responses were received from Jan-June 2023 during R submission working group meetings. The FDA response commented on minor findings on warnings and recommended best practices on filters, documentation and package source. The updated submission package addressed reported issues and was submitted on July 19, 2023. The final response letter from FDA was received on Sept 27, 2023.
As a next step, the R Consortium R Submission Working Group initiated submission pilot 4, to explore the use of novel technologies such as Linux containers and web assembly to bundle a Shiny application into a self-contained package, facilitating a smoother process of both transferring and executing the application.
The initial announcement of the R Consortium R Submission pilot 2 can be found at:
Announcement of the R Consortium R submission pilot 1: