FDA clarifying what constitutes minor use of drugs under MUMS Act

The Food and Drug Administration has proposed amending regulations relevant to the development of drugs for minor uses in major species to specify what constitutes a “small number of animals” needing a drug. Sponsors who develop such drugs qualify for incentives under the Minor Use and Minor Species Animal Health Act.

The purpose of the MUMS Act is to encourage the development of drugs for minor species as well as for minor uses in major species. The major species are cattle, horses, swine, chickens, turkeys, dogs, and cats.

In its March 18 proposal, the FDA presented an analysis of the threshold number of animals for each major species that represent a drug market value insufficient to prompt a sponsor to develop the drug in the absence of the MUMS Act incentives. The agency evaluated food-producing animals separately from nonfood-producing animals.

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