FDA Artificial Intelligence and Machine Learning for Biological and Other Products Regulated by CBER (Catapult’s regulatory round-up – March 2024)

Since 2016, CBER has identified an increasing use of artificial intelligence and machine learning (AI/ML) in IND submissions of vaccines, cellular products, and gene therapies. Currently, there are 70 IND applications with AI/ML, used in several disciplines (e.g., clinical, CMC, pharmacovigilance) which involve prediction, classification, clustering, and anomaly detection. CBER supports the validated use of AI/ML throughout the product life cycle to expedite product development and approval, and support effective product oversight. CBER coordinates its AI/ML activities through the Artificial Intelligence Coordinating Committee (AICC). The AICC is executing a strategy focusing on staff education, communication, facilitating review of AI/ML in submissions, and project tracking and submission landscaping. Please find further information here.

Published on the 2nd of April 2024 in Catapult’s regulatory round-up for March 2024.