FDA Calls Virtual Meet on Pet Drug Fees—Speak Up by 2027
Published Date: 4/17/2026
Notice
Summary
The FDA is hosting a virtual meeting on May 27, 2026, to talk about the Animal Generic Drug User Fee Act (AGDUFA) and wants your ideas for improving it. This affects companies making generic animal medicines and could change fees or rules in the future. You can share your thoughts online until December 1, 2027, so don’t miss your chance to help shape the program!
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Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
AGDUFA Expires September 30, 2028
The authority for the Animal Generic Drug User Fee Act (AGDUFA) expires on September 30, 2028. Without new legislation, the FDA will no longer have the authority to collect user fees that help fund the animal generic drug review process for future fiscal years, which directly affects companies that pay those fees and rely on the review process.
Meeting and Long Comment Window to Influence AGDUFA
The FDA will hold a virtual public meeting on May 27, 2026 from 11 a.m. to 1 p.m. Eastern Time; you must register by midnight ET on May 22, 2026 and requests to give oral presentations are due by May 1, 2026. The public comment docket is open until December 1, 2027 (electronic comments accepted through 11:59 p.m. ET on December 1, 2027), and comments suggesting changes received by July 1, 2026 will be published on FDA's website.
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