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CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species

This guidance assists those interested in pursuing FDA approval of new animal drugs intended for use in minor species or for minor uses in major species. It outlines the basic requirements and special considerations, as well as available incentives to encourage development of these drugs. ....

Drug Administration , Minor Species Animal Health , Guidance Issuing Office , Docket Number , Minor Use , Minor Species Animal Health Act ,