Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Draft Guidance for Industry; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GFI) #61 entitled "Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species." This draft guidance is intended to assist those interested in pursuing FDA approval of new animal drugs intended for minor uses in major species or for use in minor species (MUMS drugs). It outlines the basic statutory and regulatory requirements and special considerations for these approvals, and describes the incentives available to encourage the development of MUMS drugs.