For Industry

ADUFA Meetings

         

Industry Discussions on ADUFA IV 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.

Page Last Updated: 11/21/2016
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