Inside the FDA: What’s Happening Now and What’s Coming Next?

For more than two decades at the FDA, Dr. Richard Pazdur stood at the center of drug regulation as Director of the Center for Drug Evaluation and Research and the Oncology Center of Excellence. Now, in this exclusive and candid conversation, he steps outside the agency to share the insider view few ever hear.

The FDA’s expectations around supply chain security have shifted dramatically in response to tariff pressures, reshoring mandates, and heightened national security concerns. Drawing directly from his 26 years shaping FDA policy, Dr. Pazdur reveals how regulators are assessing vulnerabilities, what compliance standards are being enforced today, and how these changes are reshaping approval pathways and market access for every company supplying the US market.

This session delivers the rare, unfiltered regulatory intelligence needed to move beyond guesswork, showing exactly how FDA thinking is evolving and what it means for risk mitigation, diversification strategies, and long-term competitiveness in the US pharmaceutical sector. If you want to understand the regulatory landscape, its impact on your supply chain, and how to turn these challenges into opportunities, this is the session you can’t afford to miss.