Regulatory initiatives for artificial intelligence applications: Regulatory writing implications

Abstract

Applications of artificial intelligence (AI)/ machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to ensure safe and effective use. This article explores the utilisation and opportunities in three areas: medical devices (built-in software applications); post-marketing surveillance (processing of large volumes of reported adverse reactions); and clinical development (pharmacokinetic profile, dose selection, clinical trial design, and regulatory writing). AI/ML-based applications are not perfect. Potential risks are enormous. Continued public/private engagement, vigilance, and oversight for all parties is essential for successful utilisation of these tools.