FDA publishes discussion paper on AI in drug manufacturing

Building on FDA’s work to enhance advanced manufacturing initiatives, the agency today released a new discussion paper about applying AI in pharmaceutical manufacturing. At a high level, while the agency sees a developing role for these technologies in quality measures and other complex data analytics, there are regulatory questions.

Regulatory Background

  • Advanced manufacturing is: “a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time to market,”  according to the FDA.

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