RConsortium/submissions-pilot3-adam

Development repo for pilot3 submission to FDA - ADaM

Overview

The objectives of the R Consortium R Submission Pilot 3 Project are:

1. Deliver a publicly accessible R-based Submission through the eCTD portal
2. 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:

1. Project Background/Setup - Scope of work, what we used and how we used it.
2. Deliverables - What was sent to the FDA - Cover Letter, TLFs, Datasets, ADRG.
3. Conferences - Proceedings from different conferences on Pilot Submissions
4. 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)

• 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.

• 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.

• R Consortium's R-based Test Submission Package for FDA Evaluation: A Milestone in R-based Regulatory Submissions

  • Pilot 3 Demo: R/Medicine 2024 Demo Day, Wednesday, June 12, 2024 10:00AM-10:55AM EST

• A Milestone and a new Frontier in R-based Regulatory Submissions - Pilot 3 Demo : useR! 2024 On-line talk

  • The R Consortium is delighted to share knowledge of the successful submission of an R-based test submission Pilot 3 package through the FDA eCTD gateway by the R Submissions Working Group. This groundbreaking achievement marks one of the early publicly available R-based FDA submission packages, including R scripts for generating analysis data model (ADaM) datasets and tables, listings, and figures (TLFs). The package adheres to eCTD specifications and serves as a valuable reference for future R-based regulatory submissions.

Get in Touch

Don't be shy! We like to chat about R and Submissions. Find us on pharmaverse slack