The Food & Drug Administration announced April 28 that it 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 June 29, 2016.
In 2014, FDA began seeking public comment as it continued to explore possible modifications to the procedures and requirements for the approval of combination drug medicated feeds. Currently, the use of multiple new animal drugs in the same medicated feed requires an approved NADA for each new animal drug in the combination and a separately approved NADA for the combination new animal drug itself. The intent of this exploration is to consider changes intended to allow combination drug medicated feeds to be made available to the end user in the most efficient manner possible while protecting and promoting the public health.
FDA published a Federal Register notice seeking comment on this initiative (79 FR 53431) on Sept. 9, 2014, and held a public meeting on March 16, 2015 (80 FR 8092). Before and since that public meeting, the agency has met with stakeholders to receive input on this issue.
FDA encourages interested stakeholders to submit comments to the docket (FDA-2014-N-1050) before June 29.
More information is available at http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm459067.htm.