Signal // April 28, 2026
FDA's AI trial pilot just went live. The real-time submissions era begins.
FDA launches effort to speed up clinical trials, using AI
FDA's real-time AI trial pilot with AstraZeneca and Amgen is the most significant regulatory AI development of Q1-Q2 2026. For medical writers documenting trial data: the review dynamic is changing on both sides of the submission.
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program — Request for Information
The primary regulatory source document. If you are advising on US regulatory strategy or writing clinical documents, this RFI is required reading. Comment period is open.
Why conversations around health AI may be evolving beyond hype
STAT's April analysis marks a signal shift: the discourse is maturing. Health comms leadership should be ahead of this framing — not just aware of it.
That's it for this edition. Back next week.
— Ned