Guidance for Industry: Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#121) entitled "Expedited Review for New Animal Drug Applications for Human Pathogen Reduction Claims." The guidance provides advice to industry about the process that the Center for Veterinary Medicine (CVM) plans to use to grant expedited review status (ERS) for applications for new animal drugs intended to reduce human pathogens in food-producing animals.