AI in Regulatory Review: Balancing the Promise and Pitfalls at FDA
AI tools like Elsa help the FDA by summarizing reports and reducing paperwork, but about one in five of Elsa's reports have fake or wrong information. This raises concerns about overreliance and missed mistakes, though leaders are optimistic about fixes. Most staff use Elsa only for simple tasks, and the FDA is now transparently reporting errors to build trust and guide other agencies.