Signal // February 10, 2026
The FDA is using it. Sanofi’s CEO is naming it. The BfArM pilot is running.
As FDA Deploys Agentic AI, Pharma Begins Testing the Next Frontier of Intelligent Automation
The FDA is using agentic AI internally. When both the regulator and the sponsor are using AI, the review dynamic changes. This is not a future scenario — it’s the operational context for submissions now.
Sanofi CEO: The enterprise AI shift will reshape pharma in 2026
Paul Hudson’s framing of AI across R&D, manufacturing and medical communications is the clearest public statement from a major pharma CEO on what operationalised AI looks like in practice. The comms function is explicitly in scope.
AI streamlines pharma regulatory review: BfArM pilot tackles 19,000 annual submissions
Germany’s BfArM is running a live AI pilot automating regulatory submissions using LLaMA 3. This is the clearest European proof-point that AI is in the regulatory submissions workflow — now.
Medical Writing 2026: Adapting to AI and Rising Complexity
The market is polarising between commoditised generalists and premium regulatory specialists. If you’re not sure which side you’re on, that’s the most useful data point in this article.
That's it for this edition. Back next week.
— Ned