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.
The Evolving Role of AI in the FDA
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.
Integration of AI Tools
They address how the FDA is beginning to integrate AI tools like “Elsa” to improve efficiency in inspections, data analysis, and safety monitoring. This integration signifies a substantial shift in regulatory practices, aiming to enhance the agency’s operational effectiveness.
Regulatory and Compliance Challenges
Brigid also explores key regulatory and compliance challenges surrounding AI-driven clinical decision support software, emphasizing the importance of explainability and human oversight. As AI technologies advance, ensuring that these systems are understandable and controllable by human operators becomes crucial.
New Approach to Transparency
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. Enhanced clarity in communications could foster better relationships between the FDA and stakeholders in the life sciences sector.
