Human User Safety in New and Abbreviated New Animal Drug Applications; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #278 (GFI #278) entitled "Human User Safety in New and Abbreviated New Animal Drug Applications." Human User Safety (HUS) is an integral component of the overall safety evaluation of proposed new animal drugs. FDA is issuing this guidance to clarify the current approaches and recommendations of FDA's Center for Veterinary Medicine (CVM) for HUS assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.