FDA opens public input on next animal drug user fee cycle

The FDA is opening the next round of public input on two animal drug user fee programs, with virtual meetings set for May 27, 2026, for the Animal Generic Drug User Fee Act, or AGDUFA, and the Animal Drug User Fee Act, or ADUFA. The agency said stakeholders can register to attend, request time for oral presentations, and submit written comments as it begins considering what should be included in the next reauthorization cycle. FDA posted the announcement on April 28, 2026, and said the current ADUFA V program runs through fiscal year 2028, not September 30, 2026, as some secondary coverage indicated. The public meetings are scheduled for 11 a.m. to 1 p.m. Eastern for AGDUFA and 2 p.m. to 4 p.m. Eastern for ADUFA, both by webcast. (fda.gov)

Why it matters: User fee programs help fund FDA’s review of new and generic animal drugs, supporting review timelines, predictability, and staffing at the Center for Veterinary Medicine. For veterinary professionals, those programs can shape how quickly new therapies, label expansions, and generic alternatives move through the pipeline, with downstream effects on treatment access, clinic purchasing, and what pet parents can afford. FDA says comments will stay open through December 1, 2027, giving manufacturers, trade groups, veterinarians, and other stakeholders a long runway to weigh in. (fda.gov)

What to watch: Watch for stakeholder comments, possible industry asks around review efficiency and communication, and eventually FDA’s negotiated recommendations to Congress as the reauthorization process moves forward. (fda.gov)