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Cost Of Reviewing Drugs With AI Is ‘Prohibitive’ For US FDA

 
• By Sarah Karlin-Smith

A public-private partnership or other solution may be needed for the FDA to handle the costs of reviewing the growing number of drug applications with AI and machine learning components, CDER Director Patrizia Cavazzoni said.

Super Computer
The FDA lacks the necessary funding to review applications with AI and machine learning. • Source: Shutterstock

The US Food and Drug Administration is concerned about the “prohibitive costs” of the high-performance computers required to review drug applications with artificial intelligence as it sees “a real uptick” in the number of investigational new drug applications and more advanced development programs making use of the technology.

“We are looking at how to expand our capabilities, really build out capabilities when it comes to ingesting data and...

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