The R Consortium is happy to announce that on Nov 18th, 2022, the R Submissions Working Group successfully submitted a test submission package with a Shiny component through the FDA eCTD gateway! The submission package has been received by the FDA CDER staff. 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 application was built using the source data sets and analyses contained in the R submission Pilot 1 Project.

To our knowledge, this is the first publicly available submission package that includes a Shiny component. We hope this submission package and our learnings can serve as a good reference for future regulatory submission efforts, when considering Shiny as a tool for a more user-friendly interface to navigate through analysis results. Additional agency feedback will be shared in future communications.

To learn more about the R consortium R submission Working Group and the Pilot 1 submission, more information can be found at:

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