Zdrowie i gospodarka · 09/03/2015

FDA Releases Revised Guidance for Veterinary Industry on Veterinary Drug Residue Depletion Studies

The Food and Drug Administration (FDA) has released a revised guidance document (GFI #208) for the veterinary industry, which updates a previous guidance on evaluating the metabolism and residue kinetics of veterinary drugs in food-producing animals. The document, developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), outlines criteria for validating analytical methods used in residue depletion studies, as agreed upon by the European Union, Japan, United States, Australia, New Zealand, and Canada.