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FDA announces AI rollout timeline and scientific review pilot completion

Image of the sign of the FDA headquarters in Maryland.
Photo: Sarah Silbiger/Getty Images

Julie DiMauro

2 min read
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The FDA said its timing to scale use of AI inside its FDA centers follows the completion of a GenAI pilot for scientific review.

In what the agency called “a historic first,” FDA Commissioner Martin Makary announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, following the completion of a new generative AI pilot for scientific reviewers.

The generative AI tools allow FDA scientists and

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