The Animal Drug User Fees for both Pioneer and Generics applications have been announced! The Federal Register (FR) Notices can be found here: ADUFA FY2027 and AGDUFA FY2027. See the Lachman Blog for additional user fee blogs: GDUFA, BSUFA, PDUFA, and Outsourcing.
As a reminder, ADUFA V (FY2024-FY2028) allows for an adjustment for inflation and workload each fiscal year; beginning in FY2025, the annual fee revenue is subject to an operating reserve adjustment, which may lead to an increase or decrease in the fee revenues. For FY2027, there is good news for Pioneer/Innovator Animal Health companies, as all fees except for the Establishment Fee have decreased between 8-12%. Though this does not quite make up for the increases seen in FY2026, it will be a welcome relief, nonetheless.
There is a potential waiver for one or more ADUFA fees if the fee would present a significant barrier to innovation because of limited resources, as discussed in the CVM Guidance for Industry shown here: CVM GFI #170. Other waivers and fee reductions are discussed in the FR notice ADUFA FY2027, Section VIII.
For the second year in a row, the ANADA and Product fees for Generic Animal Drugs decreased, though sponsor fees increased a bit. Those in the animal health industry will likely remember that from FY24 to FY25, the application fees increased almost 28%! However, with the decrease in fees in the past two years, the net difference from FY24 to FY27 was less than a 5% increase across the board.
Waivers or reductions remain available for generic new animal drugs intended solely for a minor use/minor species (MUMS) indication.
The application fee rates apply to applications submitted on or after October 1, 2026, and will remain in effect through September 30, 2027. For both ADUFA and AGDUFA fees, any application/submission fees for NADAs, ANADAs or to establish a JINAD file must be made 1-2 days prior to the submission’s arrival to 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, 2026 for product and sponsor fees, with payment due by January 31, 2027.
