FDA Seeks Comments on Combination Drugs

August 25, 2015 — 

The FDA is considering changing the approval process for drugs used in combination in medicated feeds. Currently, the use of combined drugs in a medicated feed requires an approved new animal drug application (NADA) for each drug individually, and a separate NADA for the combination. The FDA says it is exploring changes to allow combination drug medicated feeds available in an efficient manner while protecting public health. [Source: Cattle Network, by John Maday]

The FDA published a Federal Register notice seeking comment on this initiative on September 9, 2014, and held a public meeting in March, 2015. The agency plans to publish draft recommendations based on stakeholder feedback, and the draft recommendations then will be open for public comment. The FDA now encourages interested stakeholders to submit comments to the docket (FDA-2014-N-1050) by September 9, 2015, prior to the development of draft recommendations.