Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA is hosting a virtual public meeting to gather input on reauthorizing the Animal Generic Drug User Fee Act, which funds the generic animal drug review process. Key stakeholders, including industry representatives and the public, are invited to provide feedback on what features should be included in the next iteration of the Act. Comments can be submitted until December 1, 2027, which will help shape the legislation set to expire in 2028.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Public meeting scheduled to discuss the AGDUFA reauthorization.
- Input requested on future features of the AGDUFA program.
- Comment period open until December 1, 2027.
Obligations
What this law requires
Individuals interested in attending the public meeting must register no later than midnight Eastern time on May 22, 2026.
Stakeholders must register to attend the public meeting on the Animal Generic Drug User Fee Act by May 22, 2026.
Individuals wishing to make oral presentations during the public meeting must submit their requests by May 1, 2026, including topics to be addressed and presentation titles.
Comments regarding changes to the Animal Generic Drug User Fee Act must be submitted electronically by December 1, 2027.
Presenters planning to use an electronic slide deck must email a copy of their presentation to the FDA by May 15, 2026.