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GUIDANCE DOCUMENT

CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods March 2015

Final

CVM GFI #207 (VICH GL48) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs In Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods

Docket Number:
FDA-2010-D-0166
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

As part of the approval process for veterinary medicinal products in food-producing animals, national/regional regulatory authorities require data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible tissues including meat, milk and eggs. The objective of this guidance is to provide study design recommendations which will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.

The guidance encompasses the most common species, namely cattle, pig, sheep and poultry; however, the principles of this guidance can also be applied to related species not mentioned in this core group (e.g., cattle vs. all ruminants). The guidance does not provide study design recommendations for fish or honey bees (as producers of honey).


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:

Division of Dockets Management (HFA- 305)
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-2010-D-0166.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
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Rockville, MD 20855
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(240) 402-7002