Human User Safety in New and Abbreviated New Animal Drug Applications; Guidance for Industry; Availability

Résumé

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #278 entitled "Human User Safety in New and Abbreviated New Animal Drug Applications." This guidance is intended for sponsors interested in pursuing the approval, or conditional approval, of new animal drugs (including new generic animal drugs). This guidance addresses general principles of human user safety (HUS) assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal drugs, potential recommendations to address HUS concerns, and how HUS information should be submitted to the Center of Veterinary Medicine (CVM).