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GUIDANCE DOCUMENT

CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species July 2018

Draft

Not for implementation. Contains non-binding recommendations.

CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species

Docket Number:
FDA-2018-D-2354
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements for drugs intended for using in aquatic food-producing species.

This document is an extension to the parent residue guidance: CVM Guidance for Industry (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.” This guidance, VICH GL57, provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.

Metabolism studies based on CVM GFI #205/VICH GL46, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues,” can be used in aquatic food-producing species to identify a marker residue.


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-2018-D-2354.

Questions?

Contact Point
Julia Oriani
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Food and Drug Administration
7500 Standish Place, HFV-151
Rockville, MD 20855