2025 FDLI Annual Conference
May 15 – 16
Ronald Reagan Building and International Trade Center | Washington D.C.
About the Conference
The AgencyIQ Team will be attending the 2025 FDLI Annual Conference, at Ronald Reagan Building and International Trade Center, in Washington D.C. The annual event, hosted by Food & Drug Law Institute (FDLI), is the premier event for the food and drug law community.
See Us There
The AgencyIQ Team will be attending sessions as well as hosting an exhibitor booth. Visit us to connect with our team of regulatory experts, experience AgencyIQ’s subscriber dashboard, access exclusive content, sign up for our free food regulation newsletter, FDA Today: Food and receive gifts.
Attend Our Sessions
Driving Policy Reform Through FDA’s Budget: User Fees, Appropriations, and Stakeholder Engagement
Friday, May 16
1:25pm – 2:25pm
Moderator: Alexander Gaffney, MS, RAC – AgencyIQ
This session analyzes the administration’s current and predicted budgetary priorities in view of reauthorizations to the Prescription Drug User Fee Act (PDUFA) and the Over-the-Counter Monograph User Fee Amendments (OMUFA). Panelists discuss how FDA under new leadership is negotiating with Congress and industry stakeholders and the anticipated effect on manufacturers and public health, REMS funding, accelerated drug approvals, and OTC drug quality.
The QSR to QMSR Transition: Complying with a New FDA Strategy
Friday, May 16
1:25pm – 2:25pm
Speaker: Laura DiAngelo, Senior Director, Research – AgencyIQ
This session addresses the preparation gap between domestic and global manufacturers as the device industry shifts from Quality System Regulation (QSR) to Quality Management System Regulations (QMSR). Domestic companies still operating under QSR face greater pressure to adopt risk-based quality management throughout total product lifecycle. Experts offer strategies to shift current practices toward QMSR expectations from insights in QSR-focused warning letters, examples of successful adaptation to the new model in various markets, and the role of device regulator forums in accelerating the transition.
Request an appointment now to reserve a dedicated meeting time that works best for your schedule.
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