FDA is hosting public meetings to discuss drug user fee legislation

Officials with the FDA have announced virtual public meetings to discuss the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUF) programs. The meetings, scheduled for May 27, 2026, will also address suggestions about the features the FDA should consider for the next reauthorization of both user fee programs.¹

The ADUFA and the AGDUF programs expire September 30, 2026. In the absence of new legislation, the FDA will no longer have authority to collect user fees for funding the new animal drug review process and the new animal generic drug review process in future fiscal years. According to the FDA, the agency considers the timely review of new animal drug and generic new animal drug submissions to be central to its mission of protecting and promoting human and animal health.^2,3

The ADUFA Public Meeting will be held 2 PM to 4 PM EDT, while the AGDUFA Public Meeting will be held 11 AM to 1 PM EDT. Both meetings will be hosted via a live webcast.^1-3

Individuals interested in attending either or both meetings must register in advance, no later than midnight EDT on May 22, 2026. Registration can be completed by emailing full contact information for each attendee—name, title, affiliation, address, email, telephone number and any reasonable accommodations required for a disability, such as closed captioning, if needed—to the following addresses¹:

• ADUFA Public Meeting: [email protected]
• AGDUFA Public Meeting: [email protected]

Registration to attend these meetings is free, and the FDA recommends registering early. Attendees will receive confirmation when their registration is received, and the FDA will provide the webcast link.¹

Those interested in making an oral presentation during a public meeting should also indicate that intention in the registration email. Presentation information should include the topics an individual wishes to address as well as the title of the presentation. According to the FDA, agency officials will do their best to accommodate requests to make an oral presentation. However, individuals and organizations with common topic interests are encouraged to consolidate or coordinate their presentations and request time for a joint presentation, or submit requests for designated attendees to participate. Requests to make oral presentations must be received by May 1, 2026.¹

Dockets for ADUFA and AGDUFA will remain open for public comment during the reauthorization process, until December 1, 2027. Written or electronic comments must reference their docket numbers. The ADUFA docket number is FDA-20110-N-0656. The AGDUFA docket number is FDA-2011-N-0655.¹

For additional instructions for written and electronic comments and to submit an electronic comment visit the Federal Register online for ADUFA and AGDUFA.^2,3

References

1. FDA announces 2026 virtual public meetings and comment periods on reauthorization of user fee programs for animal drugs and generic animal drugs. FDA. April 28, 2026. Accessed April 29, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-2026-virtual-public-meetings-and-comment-periods-reauthorization-user-fee-programs?utm_medium=email&utm_source=govdelivery
2. Animal Drug User Fee Act; public meeting; request for comments. Federal Register. April 17, 2026. Accessed April 29, 2026. https://www.federalregister.gov/documents/2026/04/17/2026-07498/animal-drug-user-fee-act-public-meeting-request-for-comments
3. Animal Generic Drug User Fee Act; public meeting; request for comments. Federal Register. April 17, 2026. Accessed April 29, 2026. https://www.federalregister.gov/documents/2026/04/17/2026-07497/animal-generic-drug-user-fee-act-public-meeting-request-for-comments