FDA Issues Final Guidance to Assist Sponsors of Animal Drugs for Minor Uses and Minor Species (MUMS)

The U.S. Food and Drug Administration has released updated information to help animal drug researchers and sponsors navigate the pathway to approval for animal drugs intended for minor uses and minor species (MUMS).

The final guidance, entitled, “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” was released as a draft guidance in July 2020 for public comment. The comment period was extended to 180 days in order to hear from all interested parties. The agency received many comments on the proposed Aquaculture Species Grouping section of the draft guidance; the agency intends to address aquaculture species grouping in greater detail in the future. Other revisions were made in response to public comments and to improve clarity.