US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year

 
• By M. Nielsen Hobbs
  
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Draft guidance will offer a risk-based framework for accessing the credibility of AI and help ensure that AI models used to answer regulatory questions are sufficiently credible for a particular ‘context of use,’ CDER’s Tala Fakhouri says.

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The US Food and Drug Administration is planning to issue a draft guidance on the use of artificial intelligence in regulatory decision making by the end of the year. The move would be the most concrete oversight action to date by the agency, which has been ramping up its AI activities with discussion papers, workshops and collaborations.

Key Takeaways

  • Draft guidance from FDA will take a risk-based approach to assessing AI use in regulatory decision making.

“I can’t give you the details. As much as I would love to I can’t,” Tala Fakhouri, associate director for...

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