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Food and Drug Administration and Compliance Issues
Tuesday, July 14, 2020
FDA Issues Revised Draft Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species
The U.S. Food and Drug Administration has released updated information to help researchers and animal drug sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species (MUMS).
The FDA’s mission is to protect and promote the health of both human and animals, including those animals that are considered “minor species” – animals other than those typically thought of as livestock (cattle, pigs, chickens, turkeys) or companions (dogs, cats, horses). Minor species are animals that may not be quite so common – such as sheep, goats, and ferrets, but also zoo animals, wildlife, and insects like honey bees.
Similarly, the FDA has a responsibility to facilitate approval of treatments for conditions that are relatively rare in the major species, or which occur in small numbers or in limited geographic areas. Some examples of minor uses in major species include various cancers in dogs or regional occurrences of diseases, such as outbreaks of blackhead in turkey flocks in the Southern U.S.
Because MUMS drugs, by definition, are for use in relatively small markets, there is less economic incentive for a drug company to invest in the research and development necessary to bring a product to market via the traditional new animal drug approval process.