OpenAI and the FDA Are Holding Talks About Using AI In Drug Evaluation

The Food and Drug Administration has been meeting with OpenAI to discuss the agency’s use of AI, according to sources with knowledge of the meetings. The meetings appear to be part of a broader effort at the FDA to use this technology to speed up the drug approval process.

“Why does it take over 10 years for a new drug to come to market?” wrote FDA commissioner Marty Makary on X on Wednesday. “Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s just the beginning.”

The remarks followed an annual meeting

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