When Your Life Sciences Are on the Line: AI and the FDA

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the twelfth episode of When Your Life Sciences Are on the Line, where leading practitioners and thought leaders share the insights and advice needed to manage business and legal risk in the life sciences sector. In this episode, Kate and Nate speak with Brigid Bondoc, partner and leader of Morrison Foerster’s U.S. Food and Drug Administration (FDA) & Healthcare Regulatory and Compliance Group. Together, they discuss the evolving role of artificial intelligence (AI) within the FDA and its implications for the life sciences industry. They address how the FDA is beginning to integrate AI tools like “Elsa” to improve efficiency in inspections, data analysis, and safety monitoring. Brigid also explores key regulatory and compliance challenges surrounding AI-driven clinical decision support software, emphasizing the importance of explainability and human oversight. The conversation closes with an examination of the FDA’s new approach to releasing complete response letters, and how this increased transparency may reshape industry strategies for engagement with the agency.