Navigating the New FDA Landscape: Opportunities and Challenges Ahead

In the latest episode of Conversations in Drug Development, Dr Katherine Bowen and Dr Eric Hardter discuss the ever-changing US regulatory landscape under the new administration, including new leadership and staff turnover, and their impact on drug development. They examine the FDA's cautious approach to AI, efforts to reduce animal testing, and the new National Priority Voucher Program aimed at expediting drug approvals. Tune in for an in-depth discussion that offers timely updates and expert perspectives on what might be in store for drug development stakeholders.

 

EPISODE OUTLINE

 

00:00:14 – Welcome to Conversations in Drug Development 00:01:16 – US Regulatory Environment Update 00:02:35 – Changes in FDA Leadership 00:03:19 – The Impact of Staffing Changes 00:05:54 – New Perspectives with Vinay Prasad 00:07:50 – Future of Cell and Gene Therapy Approvals 00:10:03 – Market Reactions and Funding Concerns 00:11:45 – Implications of FDA Cuts 00:12:29 – Marty McCary’s Vision for the FDA 00:14:46 – Navigating Conflicting Perspectives 00:15:45 – FDA Workforce and Operational Changes 00:17:21 – Review Process and Efficiency Challenges 00:20:43 – ELSA: AI in FDA Operations 00:22:54 – Reducing Animal Testing in Drug Development 00:25:05 – National Priority Voucher Programme Insights 00:31:21 – Future Outlook and Next Steps