This article was originally published by The Amin Law Group on March 6, 2023.
On March 1, 2023, the FDA's Center for Drug Evaluation and Research (CDER) issued a discussion paper on the role of Artificial Intelligence (AI) in the context of drug manufacturing and the implications for "measurement, modeling, and control technologies used in pharmaceutical manufacturing" (FDA, 2023).
The discussion paper referenced Current Good Manufacturing Practice(s) (CGMP) regulations and the potential "ambiguities" and discrepancies that may arise when implementing AI for new drug products, under New Drug Application (NDA); Abbreviated New Drug Application(s) (ANDA); & Biologics License Application(s) (BLA). Interestingly, the paper acknowledged gaps in the current regulatory framework considering the rapid advancements in AI. It's certainly inevitable AI will be implemented to varying degrees to speed up the manufacturing process, but it must be done so both safely and efficiently. Recent news has exuberantly highlighted the promise of AI, but it has also exposed its shortcomings.
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