Issue Date: September 2, 2026
Issued by: Center for Veterinary Medicine
Topic(s): Human Food Safety, VICH
Status: Final
CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1)
FDA is announcing the availability of a final guidance for industry (GFI) #115 (VICH GL22(R)) titled “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Testing (Revision 1).” This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this guidance is to ensure international harmonization of reproduction testing appropriate for evaluating effects on reproduction from long-term, low-dose exposures, such as those that may be encountered from the presence of veterinary drug residues in food.
Download the Guidance Document
