The FDA has released its finalized user fee rates for Fiscal Year 2026, with notable updates across several categories. These rates are effective as of October 1st, 2025, and apply through September 30th, 2026.
This regulatory update is particularly relevant for operations involving biologics, generic drugs, medical devices, outsourcing facilities, and food safety certifications. While fee adjustments are expected each year, this cycle introduces shifts that underscore the FDA’s continued emphasis on supply chain accountability and facility oversight.
