The Minor Use and Minor Species Animal Health Act of 2004 (commonly referred to as the “MUMS” Act) amended the FD&C Act to provide incentives to sponsors to develop “MUMS drugs,” that is, new animal drugs for use in minor species or for use in major species afflicted with uncommon diseases or conditions (minor uses), while ensuring appropriate safeguards for animal and human health.  

This guidance is intended to assist those interested in pursuing FDA approval of these new animal drugs. It outlines the basic requirements and special considerations for approvals of MUMs drugs and describes the incentives available to encourage their development.

Many of those seeking approval for MUMS drugs are new to the new animal drug approval process.  To better assist those who may be unfamiliar with the approval process, topics are presented in the order in which they commonly arise in the development of a MUMS drug.  Although FDA intends for this guidance to be generally useful for all parties that may pursue approval of a MUMS drug, some portions of this document contain information that applies specifically to applications for approval of MUMS drugs intended for use in aquatic species.

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