Lexology March 8, 2023
Taking another step towards embracing the use of Artificial Intelligence in prescription drug production, last week, the FDA released the discussion paper “Artificial Intelligence in Drug Manufacturing.” In the paper, FDA indicated its intention to rely on a risk-based regulatory approach for the use of AI in drug manufacturing for the time being while it builds out an appropriate regulatory framework. To build the new framework, the Agency is seeking industry feedback in several areas related to the future approval of drugs manufactured with AI technologies.
The discussion paper provides examples of future AI uses in the space. Among these applications is AI aided:
- Process design and scale-up to identify optimal production methods;
- Process monitoring and fault detection to...
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