Lexology August 6, 2024
Artificial intelligence (AI) and machine learning (ML) are having a transformative effect in streamlining processes across drug discovery, from predictive maintenance to personalised medicine and real-time quality control. U.S. Food and Drug Administration (FDA) Commissioner Robert Califf recently noted how “AI has the potential to enable major advances in the development of more effective, less risky medical products.”
However, this is a highly regulated field, and the fast evolution of AI and ML technologies is demanding the equally fast development of robust regulatory frameworks, raising some complex regulatory challenges that need to be navigated carefully. Manufacturers, therefore, need to look carefully at their use of AI and ML in good manufacturing practice (GMP) settings and ensure that they are in...
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