The objectives of the R Consortium R Submission Pilot 3 Project are:
- Deliver a publicly accessible R-based Submission through the eCTD portal
- Expand on the work done in Submission Pilot 1, by now utilizing R to generate ADaM datasets.
NOTE: This is a FDA-industry collaboration through the non-profit organization R Consortium.
What’s on the Website?
This website encapsulates the hard-work of some intrepid statistical programmers from across the Pharma Industry to demonstrate a R-based Submission to the FDA.
The website is divide into 4 sections that will walk you through our efforts:
- Project Background/Setup - Scope of work, what we used and how we used it.
- Deliverables - What was sent to the FDA - Cover Letter, TLFs, Datasets, ADRG.
- Conferences - Proceedings from different conferences on Pilot Submissions
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WG Minutes and Regulatory Feedback - Provides a menu of links in two sections.
- Section 1: Provides links to the monthly WG Meeting Minutes
- Section 2: Provides a link to the Pilot3 Team Compilation of the Regulatory Review - Pilot3 Team Interpretation(s) of the Regulatory Feedback (FDA Review Continues)
Latest News
First Publicly Available R-Based Submission Package Submitted to FDA (Pilot 3)
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Novo Nordisk’s Journey to an R based FDA Submission
- Data scientists at Novo Nordisk, a leading pharmaceutical company in diabetes, obesity, and other chronic diseases, share details of their first FDA submission package featuring outputs and ADaM datasets written exclusively in R.
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Testing Containers and WebAssembly in Submissions to the FDA
- Blog post with short summary of the R Consortium FDA Pilots 1-4 Series and the ongoing efforts undertaken to evaluate new technologies for submissions to the Food and Drug Administration (FDA). These transformative approaches, including WebAssembly and containers, hold immense potential to transform the regulatory landscape and streamline the submission process.
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PharmaSUG 2024 Submission Standards Paper
- In recent years, statisticians and analysts from both industry and regulatory agencies have increased adoption of open-source software such as R. R brings great benefits from its vibrant open-source community by providing a wealth of cutting-edge statistical tools, extension packages for interactive dashboard and documentation as well as adaptability to the latest data science trends.
Get in Touch
Don’t be shy! We like to chat about R and Submissions. Find us on pharmaverse slack