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CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products April 2009

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Data from target animal safety (TAS) studies are required for registration of veterinary products in the regions participating in the VICH. International harmonization of standards for essential TAS studies will facilitate adequacy of data and minimize the need to perform separate studies for regulatory authorities of different countries. Appropriate international standards should reduce research and development costs by minimizing repetition of similar studies in each region. Animal welfare should benefit because fewer animals may be needed. This VICH TAS guidance has been developed as a harmonized standard to aid in development of mutually acceptable TAS studies for relevant governmental regulatory bodies.

This guidance document is intended to cover TAS evaluation for any IVPP used in the following species: bovine, ovine, caprine, feline, canine, porcine, equine, and poultry (chickens and turkeys). The recommendations in this guidance may not be appropriate for registration by national or regional authorities of products for use in minor species or minor uses. The guidance does not provide information for the design of TAS studies in other species, including aquatic animals.

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-2007-D-0430.


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