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FDA says it will be 'aggressive' in adopting artificial intelligence in its labs

  • FDA Commissioner Martin Makary announced the completion of a generative AI pilot aimed at accelerating drug review, with rollout planned by June 30, 2025.
  • The pilot follows recent layoffs that reduced FDA AI experts by 75%, which likely increased urgency for automating review tasks despite known AI error risks.
  • Chief AI Officer Jeremy Walsh, formerly of Booz Allen Hamilton, will coordinate agency-wide AI integration, including the project called cderGPT co-developed with OpenAI.
  • FDA staff reported that AI shortens scientific review tasks from three days to minutes, while Makary urged valuing scientists’ time and reducing non-productive busywork.
  • The rapid AI adoption promises faster drug approvals but raises concerns about patient safety and the agency’s ability to fully understand AI model limitations.
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American Hospital Association broke the news in on Tuesday, May 6, 2025.
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