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GUIDANCE DOCUMENT

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

Final

This guidance is being distributed for comment purposes only.

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).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002