2025-04-25 Hosts Craig Lipset and Jane Myles were joined by Greg Dombal and Laura DiAngelo (Agency IQ) to discuss the rapidly changing regulatory environment in the US, particularly in the clinical research sector, and its implications for those operating in this highly regulated space. The participants discussed the impact of recent changes such as reductions in force and reorganizations on the industry, and the evolving policies at the FDA, including the concept of an intermediate clinical endpoint and the interpretation and mapping of these concepts. The team also discussed the potential changes in the FDA's organizational structure, its impact on the agency's role in international collaborations, and the need for a balance between safety and efficacy in drug development.

Resources:

• Subscribe to AgencyIQs FDA Today Newsletter here
• Megyn Kelly Show with Dr. Martin Makary, new FDA Commissioner

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