Data Management FDA says yes to R, no to your Docker image Pilot 4's review letter, J&J's hybrid pipeline, and a Pinnacle 21 gap together draw the real 2026 boundary between what R submissions can do and what reviewers can actually open.
Data Management FDA's R Pilot Review Letters: The Honest Gap Between Proof-of-Concept and Reviewer-Ready FDA's formal review letters for Pilots 4 and 5 are the first detailed public account of which R submission tooling the agency's IT environment can actually run today.