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As more regulatory bodies release guidance about the use of AI in drug and device development, the chances of not fully adhering increases.
As artificial intelligence (AI) becomes more dominant in the pharma industry, regulators have started developing guidance as to how it can be used. There are complexities however, especially for sponsors conducting global trials using AI to abide by regulation from different regions.
The US Food and Drug Administration (FDA) is in the midst of developing guidance for the use of AI and machine learning (ML) in drug development and has already released guidance on the use of AI and ML in medical devices. The European Medicines Agency (EMA) has also released draft guidance on the use of...
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