Navigating the New FDA Landscape: Opportunities and Challenges Ahead

Conversations in Drug Development

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