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GUIDANCE DOCUMENT

CVM GFI #226 Target Animal Safety Data Presentation and Statistical Analysis January 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-D-0839
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This document provides recommendations to industry regarding the presentation and statistical analyses of target animal safety (TAS) data submitted to FDA 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).

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All written comments should be identified with this document's docket number: FDA-2015-D-0839.

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