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Guidance on Target Animal Safety Data


Federal Register Notice: FDA is making available a guidance for industry entitled Target Animal Safety Data Presentation and Statistical Analysis. Its purpose is to provide recommendations to industry on the presentation and statistical analyses of target animal safety (TAS) data submitted to the Center for Veterinary Medicine as part of a study report to support approval of a new animal drug. These recommendations apply to TAS data generated from both TAS and field effectiveness studies conducted in companion animals (e.g., dogs, cats, and horses) and food animals (e.g., swine, ruminants, fish, and poultry). To download this guidance, click here. To view this notice, click here.