The FDA has reopened the comment period to seek public input on Center for Veterinary Medicine (CVM) draft recommendations for modifications to the current review processes for new animal drug applications (NADAs) for the use of multiple new animal drugs in combination drug medicated feeds.
In preparing these recommendations, CVM considered the input it previously received from the public. The period for commenting on the draft recommendations will close on July 29, 2016.
The FDA is exploring possible changes to this approval process consistent with a stated performance goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. ADUFA III authorizes FDA to collect user fees from animal drug sponsors to expedite and modernize the animal drug review process in exchange for FDA agreeing to meet a comprehensive set of performance goals to show significant improvement in the timeliness and predictability of the new animal drug review process.
To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-1050 on each page of your written comments.