Marking 10 Years: Past, Present, and Future Perspectives in FDA Law
May 14, 2026
Marking 10 Years: Past, Present, and Future Perspectives in FDA Law brought together the Gardner Law team and in-house attorney panelists to discuss what has changed over the past decade, what companies are navigating now, and what leaders should be watching next.
The program addressed privacy enforcement, cybersecurity, AI, online tracking risk, FDA strategy, QMSR modernization, inspection readiness, compliance and enforcement trends, state device licensing changes, litigation, government scrutiny, and cross-functional decision-making.
Through panel conversations, moderated discussions, audience engagement, and focused presentations, the program offered practical insight into how FDA-regulated companies can navigate overlapping risks in a rapidly changing environment.
The program has been approved for 3 CLE credits and 3 RAPS RAC recertification credits.
This conversational Q&A demystified government investigations and other high-stakes disputes by drawing on real-world experience to explain what companies should expect when scrutiny intensifies. The discussion focused on early response strategies, common pitfalls, and how regulatory, compliance, and legal teams can work together to manage risk when the government comes knocking.
This panel drew on FDA experience to examine enforcement trends, market pathways, and strategic lessons that can help companies plan more effectively for what lies ahead. Attendees gained practical insight into anticipating FDA priorities, mitigating risk, and navigating an evolving regulatory landscape with greater confidence and foresight.
This panel explored how healthcare compliance expectations have evolved over the past decade, where enforcement and program design stand today, and what regulated companies should prepare for next. Presenters shared practical perspectives on building right-sized, risk-based compliance programs that can adapt to increasing scrutiny, business growth, and operational complexity.
This session examined how U.S. privacy compliance is being shaped by new state privacy and AI laws, including developments in Indiana, Kentucky, Rhode Island, Texas, and Colorado, as well as major California updates under the CCPA/CPRA and emerging rules for automated decision-making technologies. The presenters provided a practical overview of high-impact developments, highlighted enforcement priorities, and offered concrete compliance takeaways to help companies focus on the issues most likely to matter in the year ahead.
This closing in-house counsel panel looked ahead to the strategic, legal, and operational issues most likely to shape the next decade for FDA-regulated companies. Through a moderated discussion, the panelists discussed how leaders can respond to evolving agency expectations, rising complexity across compliance functions, and the growing need for coordinated legal and business strategy.
