FDA Finalizes Report on the Regulation of Combination Drug Medicated Feeds

A working group at the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has finalized its report on proposed changes to improve the efficiency of approvals for the use of multiple new animals drugs in combination drug medicated feeds, while still protecting public health. These proposed changes are consistent with a performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter and are based on public comment. This report will be used in discussions concerning the reauthorization of the animal drug user fee program for five additional years through fiscal year 2023 (ADUFA IV).  As required by the Animal Drug Availability Act (ADAA), the use of multiple new animal drugs in the same medicated feed, also known as a combination drug medicated feed, requires animal drug sponsors to seek approval for each new animal drug used in the combination, and to seek separate approval for the combination drug itself.