FDA Calls Pet Med Makers: Chat About Generic Drug Fees Soon
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 and 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!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
AGDUFA Authority Expires 2028
The law authorizing 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.
Opportunity to Shape AGDUFA Reauthorization
The FDA is holding a virtual public meeting on May 27, 2026 from 11 a.m. to 1 p.m. ET and is asking for public comments on AGDUFA. The docket will remain open for comments until December 1, 2027, and comments suggesting changes received by July 1, 2026 will be published on FDA's website.
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