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The U.S. Food and Drug Administration (FDA) has recently discussed the potential of using artificial intelligence (AI) and machine language (ML) in the drug development process. AI/ML has the potential to transform how stakeholders develop, manufacture, use, and evaluate therapies, as well as help bring safe, effective, and high-quality treatments to patients faster. AI/ML can be used to predict which individuals would respond to better treatments and who would be at more risk of side effects, and conversational AI chatbots could be used to answer people’s questions about taking part in clinical trials. However, there are ethical concerns, cybersecurity risks, and improper data sharing associated with using AI/ML in drug development.