The FDA published two discussion papers this week to outline the potential of artificial intelligence (AI) and machine learning (ML) in developing and producing medications. AI and ML have the potential to transform how stakeholders develop, manufacture, use and evaluate therapies, and can help bring safe, effective and high-quality treatments to patients faster. AI and ML may help health care providers scan medical literature for findings and offer predictions about how individual patients may respond to certain treatment options. AI chatbots may help answer questions about clinical trials or reporting adverse events, or even create digital “twins” of patients to model a medical intervention. The FDA is already seeing an influx of drug and biological product applications referencing the use of AI and machine learning.
