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  5. Animal Generic Drug User Fee Act Virtual Public Meeting - 05/27/2026
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Meeting | Virtual

Event Title
Animal Generic Drug User Fee Act Virtual Public Meeting
May 27, 2026

Date:
May 27, 2026
Time:
11:00 a.m. - 1:00 p.m. ET
Organized By:
Organizer

On This Page:

Background

AGDUFA gives the FDA the authority to collect user fees that provide some of the funding to support the generic new animal drug review process. These resources help support the FDA’s responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application review for generic animal drugs. The AGDUFA program began in FY 2009 and is currently in the fourth authorization (AGDUFA IV). The program expires on September 30, 2028. 

The FDA has published many reports that provide useful background on AGDUFA I, AGDUFA II, AGDUFA III, and AGDUFA IV. AGDUFA-related Federal Register notices, guidances, legislation, and performance and financial reports can be found at: Animal Generic Drug User Fee Act (AGDUFA). Additionally, the FDA-TRACK Animal Generic Drug User Fee Act (AGDUFA) Performance Dashboards provide information about AGDUFA Current Performance, AGDUFA Historical Performance, and AGDUFA Goals Summary.

For more information about the AGDUFA authorizations and enhancements towards supporting that mission, please see the Federal Register notice announcing the public meeting. 

Public Meeting Information

The purpose of the public meeting is to invite public comment on the AGDUFA program and suggestions regarding the features FDA should consider for the next reauthorization of the AGDUFA program. 

The FDA is interested in responses from the public on the following two general questions and welcomes other pertinent information that stakeholders would like to share: 

  1. What is your assessment of the overall performance of the AGDUFA program thus far?
  2. What aspects of AGDUFA should be retained, changed, or discontinued to further strengthen and improve the program?

Registration

People interested in attending this public meeting must register no later than midnight Eastern time on May 22, 2026, by emailing complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and if you need reasonable accommodations due to a disability (e.g., closed captioning) to AGDUFAReauth@fda.hhs.gov. Registration is free and early registration is recommended. Registrants will receive confirmation when their registration has been received and will be provided the webcast link.

Requests for Oral Presentations

During registration you may indicate if you wish to make an oral presentation during the public meeting. To facilitate agenda development, registrants requesting to present will be asked to provide information regarding which topics they intend to address and the title of their presentation. FDA will do its best to accommodate requests to make an oral presentation.  Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate.  All requests to make oral presentations must be received by May 1, 2026.  

Submitting Written or Electronic Comments

To permit the widest possible opportunity to obtain comments on all aspects of the public meetings, the dockets will remain open for comment during the reauthorization process for AGDUFA, until December 1, 2027.

All AGDUFA comment submissions must reference Docket No. FDA-2011-N-0655. 

For detailed instructions on how to submit electronic, written, and confidential comments, see: Notice of Public Meeting; Animal Generic Drug User Fee Act; Request for Comments.

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