1. Pink Sheet

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

AI will not have a hand in drug approval decisions, an FDA official said. (Shutterstock)
Key Takeaways
  • The FDA will not use its Elsa AI platform to make decisions on drug approvals, Tala Fakhouri told the DIA Global Annual Meeting.

The US Food and Drug Administration is not using its Elsa generative artificial intelligence tool for regulatory decisions, associate director...

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