Minutes 2025-08-01

Author

Eric Nantz

Published

August 1, 2025

  • Ben Straub (GSK)
  • Gabriel Krotkov
  • HyeSoo Cho (FDA)
  • Jayant
  • Jim Rothstein
  • Joel Laxamana (Roche/Genentech)
  • Ning Leng (Roche/Genentech)
  • Phanikumar Tata (Syneos Health)
  • Robert Devine (Johnson & Johnson)
  • Sam Parmar (Pfizer)
  • Sasi Palanisamy

Pilot 5 Update

  • Team is working on the ADRG for Pilot 5
  • Aiming for a transfer to FDA reviewers near the end of August
  • Goal is to have ADRG wrapped up by middle of August
  • The team is going to adopt an approach from J&J for setting paths to relevant data directories and R files at the start of execution
  • Meeting minutes https://github.com/RConsortium/submissions-wg/discussions/150

ECTD File type feedback

  • Link to issue https://github.com/RConsortium/submissions-wg/discussions/150
  • Unique to R, many programmers write R scripts with the .R extension
  • eCTD transfer portal automatically renames any files with a capital letter are converted to lower-case
  • Package structures tend to have many file types, it may not be sustainable to try and list all of the different possible files
  • FDA does hope to have the zip archive’s file types be listed in the acceptable file list
  • In light of resources available, it could be advantageous to prune the list to the essential types and moving the “nice to have” file types could be a subsequent update
  • Certain file types such as DESCRIPTION, NAMESPACE LICENCE are actually plain-text files, but they need to be named as they are in order for an R package to be compiled correctly as a ZIP installer
  • Next steps: FDA will have internal discussion to propose the essential file types
  • Next step: Ensure that the proposed file types also include recommended use cases that could inform the updated ECTD guidance document