The FDA has issued the Draft Guidance for Industry #257 (VICH GL57) on \"Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue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.\"
The guidance is one in a series developed to facilitate the mutual acceptance of residue chemistry data for veterinary drugs used in food-producing animals by national/regional regulators. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) regions.
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.
The FDA is now accepting public comments on this draft guidance as of July 24, 2018. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2018-D-2354 in the search box. The comment period will close 60 days after publication in the Federal Register.