Both pioneer and generic animal drug user fees have been announced! The Federal Register (FR) Notices can be found here: ADUFA FY 2026 and AGDUFA FY 2026. See the Lachman blog for additional posts regarding user fees: GDUFA, BSUFA, PDUFA, MDUFA, and Outsourcing.
I’m sure that pioneer/innovator animal health companies are in a bit of shock over the huge increases in ADUFA fees of 20% to 27% across all categories! However, one must take into account that the fees between FY 2024 and FY 2025 decreased across all categories (between 9.5% and 14.9%); therefore, the changes from FY 2024 to FY 2026 result in increases, but not as huge as they seem (rates increased between 3.7% and 14.8% in the differing categories).
There is a potential waiver for one or more ADUFA fees if the fee(s) would present a significant barrier to innovation because of limited resources as discussed in Center for Veterinary Medicine (CVM) Guidance for Industry #170. Other waivers and fee reductions are discussed in the Section VIII of the FR Notice regarding ADUFA.
In contrast, the fees for generic animal drugs decreased between FY 2025 and FY 2026. Those in the animal health industry will likely remember that from FY 2024 to FY 2025 the application fees increased almost 28%! However, with the decrease in cost this year, the net difference from FY 2024 to FY 2026 was less than a 9% increase for the application fees. That doesn’t help those who submitted in FY 2025 but will certainly help those with upcoming submissions. As many are aware, the CVM implemented a Generic Investigational New Animal Drug (JINAD) File Fee in 2023 (which applied to any open JINADs at the time of implementation on October 1, 2023); therefore, though there is a significant decrease in the original ANADA fees, it still does not offset the $50,000 JINAD fee that accompanies applications.
Waivers or reductions remain available for generic new animal drugs intended solely for a Minor Use/Minor Species (MUMS) indication.
1Only one sponsor fee will be paid.
For both ADUFA and AGDUFA fees, any application/submission fees for NADAs, ANADAs, or to establish a JINAD file must be made one to two days prior to the submission’s arrival to the CVM. The date of acceptance will be reflected as the later of the dates when the submission is received or when the full payment is received. Invoices are issued by December 31, 2025 for product and sponsor fees with payment due by January 31, 2026.
