Q & A

About R based regulatory submission

  1. How to submit readable code in R to submit to the FDA?
  • Readable code can be submitted as .r files, according to the R consortium R submission working group pilot 1.
  • Analytical codes using functions in open-sourced or proprietary packages are considered readable, as long as the proprietary R packages are submitted in the way as mentioned below.
  1. How to submit proprietary R packages to FDA?

  • Proprietary packages cannot be submitted as a compressed file through the eCTD gateway.

  • However, proprietary R packages can be converted to a plain .txt file by pkglite then submitted through the eCTD gateway. FDA reviewers can use the same package to convert the .txt file back to R package. An example can be found in the R consortium R submission working group pilot 1.

  1. What if open sourced R packages are used?
  • No need to submit source code of open source packages.
  • In adrg/programtoc, include package version, its dependency packages and their versions
  • In analytical code, include appropriate library() calls.
  1. If R is used, what is needed for the ADRG?
  • If you use R it is recommended to have a section in the ADRG/programtoc that provides the FDA with:
    • R version
    • Package dependencies and their versions
    • Instructions to convert proprietary R package .txt files back to the natural format (if proprietary R packages are submitted)

About the R consortium R submission working group

  1. Who can join the working group? How can I get involved?
  • anyone can join the working group. The working group meets monthly on Friday. If you are interested in joining the monthly meetings, please contact Joe Rickert at joseph.rickert@rstudio.com.
  • You can also monitor our issue board. Any contribution/feedback are more than welcome