Are concerns on the use of open source in filings solved? (R validation in 2026)

[epijim]

Where are we with validated use of open source in 2026?

• Is the R question closed?
• How can we map this to Python and Julia, particularly where testing/documentation across packages is not standardised like R?
• Are people using the R Validation Hub tools? If not, why?

[harveyl888]

There's also the submission piece and what needs to be in place for a submission with open source to go smoothly.

From R/Consortium w/g:
The board is seeking clarity on some rumors that the FDA is now requiring SAS reporting / programming alongside any open source submissions. Is this simply one to a few reviewers who are not familiar with open source or possibly not set up to work with open source OR is this a new guideline from the FDA? Can we use the meeting with the FDA to get some sort of response to this rumor? Thank you!

We'll have a panel at R/Pharma to discuss but it might be useful to include a roundtable on open source submissions, for those who have succeeded and those who are in the process to share experiences.