diff --git a/_r_val_hub_workstream_updates.qmd b/_r_val_hub_workstream_updates.qmd index ade9658..b196e65 100644 --- a/_r_val_hub_workstream_updates.qmd +++ b/_r_val_hub_workstream_updates.qmd @@ -1,26 +1,4 @@ -## 🗝 Key Policy Updates! - -### Reminder: - -- The FDA appears to accept `.R` files through their eSUB portal[^esub]. -- The FDA has released a draft of a new _Computer Software Assurance[^csa]_ guideline - that seems to be increasingly the basis for their evaluation of R. - -:::: {.fragment} - -- R Submissions Working Group is working on Pilot 4: pioneering use of containers for delivering study analysis - - containerizing shiny app from Pilot 2 - - seeking positive health authority feedback [^pharmasug] - - [meeting minutes](https://rconsortium.github.io/submissions-wg/minutes.html) for updates - - -:::: - -[^pharmasug]: [PharmaSUG 2024 #SS-376](https://www.pharmasug.org/us/2024/papers.html#SS-376) -[^esub]: [R Consortium R Submission WG, Pilot #1](https://github.com/RConsortium/submissions-pilot1) -[^csa]: [_Computer Software Assurance for Production and Quality Systems Software: Draft Guidance for Industry and Food and Drug Administration Staff_](https://www.fda.gov/media/161521/download) - # 📜 Workstream Updates {transition="slide-in none"} diff --git a/resources/riskassessment_3_1_1.png b/resources/riskassessment_3_1_1.png new file mode 100644 index 0000000..d43c453 Binary files /dev/null and b/resources/riskassessment_3_1_1.png differ