ADUFA Meetings
2017 Public Meeting
- FDA Announces 2017 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Programs
- Notice of Public Meeting; Animal Drug User Fee Act; Request for Comments
- FDA Announces ADUFA/AGDUFA Reauthorization Draft Recommendations and Extension of Comment Period
- Animal Drug User Fee Act; Recommendations; Request for Comments; Extension of Comment Period
- ADUFA Reauthorization Performance Goals 1 and Procedures - FYs 2019 thru 2023
- ADUFA IV: Summary of the Proposed Changes to the FD&C Act and Proposed Bill Language
- ADUFA 2017 Public Meeting Recording
- ADUFA IV Public Meeting Presentation
- ADUFA 2017 Public Meeting Transcript
Stakeholder Meetings
Industry Discussions on ADUFA IV Reauthorization
- April 18, 2017 Meeting Minutes
- March 31, 2017 Meeting Minutes
- February 21, 2017 Meeting Minutes
- February 7, 2017 Meeting Minutes
- January 24, 2017 Meeting Minutes
- January 10, 2017 Meeting Minutes
- October 27, 2016 Meeting Minutes
- October 24, 2016 Meeting Minutes
2016 Public Meeting
The May 16, 2016 public meeting was held to seek public comments relative to ADUFA’s reauthorization.
- FDA Announces 2016 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Programs
- Notice of Public Meeting; Animal Drug User Fee Act; Request for Comments
- Transcript for the 2016 ADUFA Public Meeting
- FDA Presentation
- ADUFA 2016 Public Meeting Recording
Medicated Feeds Combination Working Group
FDA committed in the ADUFA III goals letter to exploring potential ways that the Agency might modify its approval process related to approval of combination medicated feeds. A working group, henceforth called the Combination Medicated Feeds Working Group and consisting of individuals from CVM and the regulated animal health industry, was assembled to identify potential modifications and provide recommendations for further evaluation.
- Report of the CVM Working Group on the Regulation of ADAA Combination Drug Medicated Feeds
- Combination Medicated Feeds Working Group Recommendations
- May 13, 2015 Meeting Minutes
- March 4, 2015 Meeting Minutes
- October 9, 2014 Meeting Minutes
- June 25, 2014 Meeting Minutes
- May 15, 2014 Meeting Minutes
ADUFA III Conditional Approval Working Group
FDA committed in the ADUFA III goals letter to explore, in concert with industry, the feasibility of pursuing statutory revisions that may expand the use of conditional approvals to other appropriate categories of new animal drug applications. The Conditional Approval Working Group, consisting of individuals from CVM and the regulated animal health industry, was assembled to identify potential modifications and provide recommendations for further evaluation.
- March 10, 2015 Meeting Minutes
- January 28, 2015 Meeting Minutes
- January 20, 2015 Meeting Minutes
- December 2, 2014 Meeting Minutes
- October 8, 2014 AHI Government Communication Committee Meeting Minutes
- October 8, 2014 Meeting Minutes
- September 9, 2014 Meeting Minutes
- August 5, 2014 Meeting Minutes
- May 13, 2014 Meeting Minutes
- February 25, 2014 Meeting Minutes