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Opening Plenary: Preparing for the Next Round of User Fee Negotiations

Thursday, June 6, 2024
9:00 AM – 10:15 AM EDT
Location: Concourse B
The FDA’s user fee programs aren’t just a funding mechanism – they’re one of the largest levers for enacting regulatory policy changes that the FDA and industry have. As regulators, trade groups, and companies gear up for the next iteration of the PDUFA, MDUFA, BsUFA, and GDUFA programs in 2027, preparations are already underway for the next rounds of negotiations.

What regulatory policies will be proposed? What changes are needed? And what changes will regulatory professionals be talking about over the next three years and beyond?

In this engaging and lively opening plenary session, hear from some of the regulatory policy professionals who have sat at the user fee negotiating table before and learn more about how user fee programs come into existence – and what we should look forward to next.