“The FDA encourages the development of safe and effective products to improve the health and well-being of all animals, including those for which there are limited options available because of the relatively small market they represent. Today, we are providing revised draft guidance to help facilitate the legal marketing of safe and effective drugs for minor uses or in minor species (MUMS).”

“Many of those seeking approval for MUMS drugs are new to the new animal drug approval process. This draft guidance provides a roadmap for these sponsors to navigate the pathway to legal marketing status for MUMS drugs. Additionally, sponsors who apply for MUMS designation status, a status similar to the “orphan drug” status for human drugs, are eligible for incentives to help defray the costs associated with the approval process, which might otherwise prevent a company from pursuing a new animal drug application.”

“The MUMS program represents our commitment to our continuing mission to help assure that safe and effective animal drugs are available to meet the health needs of a wide range of diverse species, from companion animals and livestock suffering from rare conditions, to addressing the health needs of animals as varied as elephants, honey bees, ferrets and fish.”