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.
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.
This review process falls under performance goals established under the Animal Drug User Fee Act (ADUFA) which was first enacted in 2003. The five-year act authorized FDA to collect user fees dedicated to expediting the review of new animal drug applications. ADUFA also set performance goals to expand and modernize the new animal drug review program. According to FDA, ADUFA provided a significant funding increase that enabled FDA to increase the number of staff dedicated to the new animal drug application review process. Congress renewed ADUFA in 2008 and again in 2013, extending the current act until 2018.
Click here for the Federal Register notice, including instructions for submitting comments.