FDA Reopens Comment Period for Minor Species Drug Regulations

The U.S. Food and Drug Administration yesterday reopened the public comment period for its proposal on regulating the process of designating new animal drugs to be eligible for incentives provided by the Minor Uses and Minor Species Act of 2004.

The U.S. Food and Drug Administration yesterday reopened the public comment period for its proposal on regulating the process of designating new animal drugs to be eligible for incentives provided by the Minor Uses and Minor Species Act of 2004.

Interested parties now have until Jan. 27 to comment on the proposed regulations; the original comment period expired in December.

Essentially, MUMS offers companies incentives to produce drugs for minor species, including pet birds, fish, small animals and reptiles, and rare conditions (minor uses) in major animal species such as cats, dogs and horses.

These incentives include the possible legal marketing of certain unapproved drugs, primarily aquatic remedies for pet fish, which are intended strictly for use in minor species. The incentives also include a streamlined approval process, exclusive marketing rights and even drug development grants.

The FDA first publicized its plans for how companies could apply for MUMS designation for their products in September.

Interested parties can submit their comments via government website at www.fda.gov/dockets/ecomments.

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FDA Reopens Comment Period for Minor Species Drug Regulations

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