FDA’s CDER Is Fostering Use Of Artificial Intelligence In Drug Development

Center for Drug Evaluation and Research plans to issue a request for information this year to engage stakeholders on issues related to AI and machine learning. It received 175 AI/ML submissions in 2022, up from 14 in 2020.

AI medical — FDA is focusing on use of artificial intelligence and machine learning to enhance drug development • Source: Shutterstock

The US Food and Drug Administration’s involvement in artificial intelligence and machine learning is well known on the device side. But the Center for Drug Evaluation and Research has been working under the radar to facilitate use of the technologies in drug development.

CDER officials highlighted the center’s work at a 17 February workshop on application of AI and machine learning for precision medicine, hosted by the FDA and the University of Maryland

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