This session offers a clear, general‑audience roadmap to FDA enforcement and response strategy—using clinical trial fraud as the practical lens to understand risk, regulator expectations, and what works when the government comes knocking. Led by former U.S. Attorney Michael F. Easley Jr. and former FDA Office of Chief Counsel/DOJ Consumer Protection Branch leader Clint Narver, we will translate current FDA/DOJ priorities into action‑ready guidance for legal, compliance, and regulatory leaders. We will unpack recent actions and policies, highlight red flags that trigger inspections, 483s, subpoenas, and CIDs, map who does what across FDA, DOJ, and HHS‑OIG, and show how cases escalate into misbranding, False Claims Act, and related theories. We will also how to respond when an inquiry becomes a multi‑agency investigation. Attendees will leave with practical playbooks and strategies that resonate with enforcement authorities.

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