What is artificial intelligence and machine learning?
Artificial intelligence (AI) and machine learning (ML) are branches of computer science, statistics, and engineering that use algorithms or models to perform tasks and exhibit behaviors such as learning, decision-making, and prediction. ML is considered a subset of AI, allowing models to be developed by training algorithms through data analysis without explicitly programming the model.
What role will AI/ML play in drug development?
FDA recognizes the increasing use of AI/ML across the drug development lifecycle and across therapeutic areas. In fact, the FDA has seen a significant increase in the number of drug and biologics submissions with AI/ML components over the past few years, with more than 100 submissions reported in 2021. These applications span the landscape from drug discovery to drug development. From clinical research to post-market safety surveillance and advanced drug manufacturing.
Additionally, AI/ML is increasingly being integrated into areas where the FDA is actively working, such as digital health technology (DHT) and real-world data (RWD) analytics.
What is the FDA’s position on the use of AI/ML in drug development?
FDA is committed to fostering innovation in drug development while ensuring drug safety and efficacy. Like any innovation, AI/ML creates opportunities and new and unique challenges. To meet these challenges, FDA is accelerating efforts to build an agile regulatory ecosystem that can foster innovation while protecting public health.
As part of this effort, the FDA’s Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiation Health (CDRH), has published an initial discussion paper on various Engage with stakeholders to explore relevant considerations for the use of AI/ML in drug and biologics development. The agency will continue to solicit feedback as it advances regulatory science in this area.
AI/ML will undoubtedly play an important role in drug development, and the FDA will develop and adopt a flexible, risk-based regulatory framework that fosters innovation and protects patient safety.
