FDA Policy/General

Animal MUMS Drug Guidance

FDA has published a guidance, Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species. The document outlines the basic requirements and special considerations for approval of new animal drugs intended for minor uses in major species or for use in minor species. It also describes the incentives available to encourage the development of new animal drugs for minor uses and minor species (MUMS drugs).

Many of those seeking approval for MUMS drugs are new to the animal drug approval process, the guidance says, and thus topics are presented in the guidance in the order in which they commonly arise in the development of a MUMS drug.

The guidance includes an Introduction; Definitions; Background on the MUMS Act; Things to Consider Before Pursuing Approval of a MUMS drug; User Fee Waivers and MUMS Status; New Animal Drug Files and Submissions; Talk with the Center for Veterinary Medicine About the New Animal Drug Approval Requirements for Your Product — Presubmission Conference; Tests of Sameness; Designation; Protocol Development and Next Steps; New Animal Drug Applications; Effectiveness; Reasonable Expectation of Effectiveness for Conditional Approval; Target Animal Safety; Human Food Safety; Environmental Impact; Chemistry; Manufacturing; and Controls; Labeling; All Other Information; Post-Approval Requirements; Other Incentives and Assistance Available for Minor Use and Minor Species Projects; and two appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome