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The FDA is set to release new guidance on artificial intelligence in pharmaceutical research, consolidating three AI working groups into one council. This initiative follows extensive feedback from over 800 comments submitted by 65 organizations in response to a 2023 discussion paper. The FDA has reviewed more than 500 drug submissions utilizing AI between 2016 and 2022, indicating a growing integration of AI in drug development.
AI applications in drug development include patient stratification in clinical trials and enhancing trial efficiency. The FDA maintains that its evidentiary standards will not change, emphasizing the importance of understanding how AI models are built and trained. Challenges remain in accessing fit-for-purpose data, which is crucial for improving AI model training.
• FDA plans new AI guidance based on extensive organizational feedback.
• AI is increasingly used in drug development and clinical trial efficiency.
AI is being integrated into pharmaceutical research to enhance drug development processes.
ML applications are being deployed at scale by companies like UnitedHealth Group to optimize healthcare services.
The article highlights the need to address data silos to improve AI model training in healthcare.
UnitedHealth Group's initiatives in AI are aimed at making healthcare more efficient and accessible.
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