Additional task/item/goal of the working group - to provide a white paper on how to use a R product in a submission?

[sclewis23]

Hi Team,
I wanted to see if we could add a task/item/goal to prepare a white paper on how to use a R product in a submission to the FDA (other agencies)?
I'm new to the working group but thought providing a white paper for others in the industry on how to use a R product in a submission, could be a great outcome from this working group.

Or is the ultimate goal to have the FDA (other agencies) provide some minimal acceptance criteria (guidance) when submitting a R product in submissions?

[elong0527]

I hope Chapter 12-14 of the r4csr book https://r4csr.org/submission-overview.html covers some relevant information.

There are many ways to handle the submission work. We just provided one possible solution.