#3. FDA Guidance: AI in Drug and Biological Product Regulatory Decisions (01/30/2025)

This podcast details draft guidance from the FDA that considers using artificial intelligence to support regulatory decision-making for drugs and biological products. It proposes a risk-based credibility assessment framework for evaluating AI models throughout the drug product lifecycle, excluding drug discovery and operational efficiencies without direct patient impact. The document recommends early engagement with the FDA to discuss AI model use and includes various contact points for application areas like clinical trials, manufacturing, and pharmacovigilance. While non-binding, this guidance reflects the FDA's current thinking on ensuring the reliability of AI-generated data used in regulatory submissions. Produced by Dr. Jake Chen