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ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality

FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing

The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.