Signal // January 14, 2026
The regulators just agreed. The question is whether your governance did too.
EMA and FDA set common principles for AI in medicine development
The first transatlantic regulatory alignment on AI in drug development. Any health comms team managing AI-generated content across US and EU markets now has a shared compliance baseline. Read this. Cite it in your frameworks.
FDA and EMA Provide Guiding Principles for AI in Drug Development
McGuireWoods’ practitioner analysis of the joint principles and their workflow implications. If you haven’t updated your AI governance documentation since January 14, you’re already behind.
How Agentic AI is Reclaiming 40% of Pharmacovigilance Capacity
Agentic AI is already processing adverse event reports and multi-language ADRs at scale. Medical writers in safety communications need to understand this — not because the jobs are gone, but because the baseline has moved.
That’s it for this edition. Back next week.
— Ned