Marking 10 Years: Past, Present, and Future Perspectives in FDA Law
May 14, 2026
Join us for a special CLE program celebrating a decade of Gardner Law and examining how FDA law and life sciences compliance continue to evolve. Marking 10 Years: Past, Present, and Future Perspectives in FDA Law will bring together the Gardner Law team to reflect on key developments over the past decade and to discuss the regulatory, compliance, privacy, commercial, and litigation issues that will shape the next one.
The event will be both in-person in charming downtown Stillwater and livestreamed, so attendees can participate from anywhere. In-person attendees are also warmly welcome at our happy hour reception to follow.
The program will feature a dynamic format that blends panel conversations, moderated discussions, audience engagement, and focused presentations. Together, these sessions will offer practical insight into how companies operating in FDA-regulated industries can prepare for increasing regulatory complexity, enforcement scrutiny, and evolving compliance expectations.
Program Details
1:00 – 1:40 p.m.
When Issues Escalate: A Discussion on Litigation & Government Strategy
Presenters: David Graham and Amanda Johnston
This conversational Q&A will demystify government investigations and other high-stakes disputes by drawing on real-world experience to explain what companies can expect when scrutiny intensifies. The discussion will focus on early response strategies, common pitfalls, and how regulatory, compliance, and legal teams can work together to manage risk when the government comes knocking.
1:40 – 2:15 p.m.
From the Past to the Present: Leveraging FDA Experience to Shape Future Strategy
Moderator: Nathan Downing
Panelists: Rebecca Zadaka, Brynn Stanley, and Darya Lucas
This panel will draw on FDA experience to examine enforcement trends, market pathways, and strategic lessons that can help companies plan more effectively for what lies ahead. Attendees will gain practical insight into anticipating FDA priorities, mitigating risk, and navigating an evolving regulatory landscape with greater confidence and foresight.
2:15 – 2:50 p.m.
A Decade of Compliance: How Expectations Have Evolved, and What Comes Next
Presenters: Amanda Johnston, Lisa Damhof, and Jacob Leys
This panel will explore how healthcare compliance expectations have evolved over the past decade, where enforcement and program design stand today, and what regulated companies should be preparing for next. Panelists will share practical perspectives on building right-sized, risk-based compliance programs that can adapt to increasing scrutiny, business growth, and operational complexity.
2:50 – 3:00 p.m.
Refreshment Break
3:00 – 3:35 p.m.
Privacy Discussion on U.S. Enforcement & Compliance Hotspots
Presenters: Paul Rothermel and Josh Arkulary
As 2026 begins, U.S. privacy compliance continues to be 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. This session will provide a practical overview of high-impact developments, highlight enforcement priorities, and offer concrete compliance takeaways to help companies focus on the issues most likely to matter in the year ahead.
3:35 – 4:15 p.m.
FDA Leadership Perspectives for the Next Decade: An Industry Panel Discussion
Moderator: Mark Gardner
This closing panel will look ahead to the strategic, legal, and operational issues most likely to shape the next decade for FDA-regulated companies. Through a moderated discussion, the session will explore how leaders can respond to evolving agency expectations, rising complexity across compliance functions, and the growing need for coordinated legal and business strategy.
4:15 – 5:30 p.m.
Networking Reception
Following the program, in-person attendees are invited to stay for a networking reception with the Gardner Law team and peers from across the life sciences industry.
Join Us
Whether you attend in Stillwater or via livestream, Marking 10 Years will offer a thoughtful look at how FDA law and life sciences compliance have changed and where they are headed next. We invite you to register below and join colleagues across the industry for an afternoon of practical insight, discussion, and connection.
