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  1. FDA User Fee Programs

ADUFA Meetings

2017 Public Meeting

Stakeholder Meetings

Industry Discussions on ADUFA IV Reauthorization

2016 Public Meeting

The May 16, 2016 public meeting was held to seek public comments relative to ADUFA’s reauthorization.

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.

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.

2012 Public Meeting

The December 18, 2012 public meeting was held to seek public comments relative to ADUFA’s reauthorization.