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UPDATE: Successful R-based Test Package Submitted to FDA

By March 16, 2022Blog

The R Consortium is happy to announce that the R Submissions Working Group successfully completed the follow-up to the original pilot 1 eCTD submission! All submission materials can be found at:

The pilot 1 test submission was an example submission package following eCTD specifications which included a proprietary R package, R scripts for analysis, R-based analysis data reviewer guide (ADRG), and other required eCTD components.

The initial submission was submitted through the eCTD gateway on Nov 22, 2021. An FDA written response letter was received on Dec 3, 2021. The FDA response commented on two minor findings and included a number of suggestions for best practices. The updated submission package addressed all of these issues and was submitted on Feb 11, 2022. The final response letter from FDA was received on Mar 14, 2022, and can be found at: .

Throughout the submission process, we successfully submitted R scripts with its natural file extension (.r) through the eCTD gateway. A proprietary R package was also submitted through the eCTD gateway. Following the submitted ADRG, the FDA staff successfully installed the proprietary and open source R packages, reran the submitted R scripts, and reproduced the analysis results. In addition, the FDA staff performed independent programming in R to evaluate the results.

To our knowledge, this was the first publicly-available regulatory submission package using open source language; this successful pilot sets an important milestone to streamline future open-source language-based submissions. 

As a next step, the R Consortium R Submission Working Group aims at initiating an R submission pilot 2 to experiment with Shiny app code submission through the eCTD gateway. In addition, the working group is also exploring R based pilot submissions to other health authority agencies globally. 

The initial announcement of the R Consortium R Submission pilot 1 can be found at: