FDA FY2027 User Fee Rates: What Drug Manufacturers & DMF Holders Need to Know
On July 30, 2026, the FDA published eleven separate Federal Register notices establishing new user fee rates for Fiscal Year 2027. These updates cover prescription drugs, generic drugs, biosimilars, OTC monograph drugs, medical devices, animal drugs, outsourcing facilities, and certain food-related programs. Most of these fees take effect October 1, 2026, and stay in place through…




