The FDA's AI reviewer hallucinates confidently, and it is already reviewing drugs
Ourtake
Regulators are reviewing medicines with a tool staff say invents studies. No binding rules currently govern it.
What happened
The US Food and Drug Administration uses Elsa, a generative AI system meant to speed drug evaluations, to review clinical protocols and assess inspection risks. According to current staff reported by CNN, Elsa frequently invents studies or misrepresents research data, and the FDA's head of AI acknowledged it could hallucinate.