FDA Issues Draft Guidance on AI in Drug Development

The U.S. Food and Drug Administration (FDA) has released its first draft guidance on the use of artificial intelligence (AI) in drug and biological product development, marking a significant step in integrating AI within the pharmaceutical industry. The guidance aims to foster innovation while ensuring safety and efficacy, addressing the exponential increase in AI-related drug submissions since 2016, particularly in oncology, neurology, and gastroenterology. FDA Commissioner Robert M. Califf emphasized the importance of a risk-based framework that supports AI's transformative potential in clinical research and product development. Additionally, the FDA published recommendations for marketing submissions of AI-enabled medical devices, focusing on maintaining safety and effectiveness throughout the product lifecycle. The guidance highlights the necessity of establishing trust in AI models' performance and defines the context of use, which is crucial for regulatory assessments. Overall, these efforts reflect the FDA's commitment to ensuring robust scientific standards while leveraging AI's capabilities to advance healthcare.