The FDA’s Center for Veterinary Medicine released final Guidance for Industry #61, entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species,” in order to better facilitate the availability of safe and effective new animal drugs for minor uses and minor species (MUMS).
FDA released a revised draft of GFI #61 in July 2020 and received many informative comments that helped shape the final version. Of additional note, the agency received a number of comments on the proposed Aquaculture Species Grouping section of the draft guidance; the agency intends to address aquaculture species grouping in greater detail in the future.
For additional information, please see the links below. I am also available to answer any questions you may have.
- Guidance for Industry: Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species
- CVM Update: FDA issues final guidance to assist sponsors of animal drugs for minor uses and minor species