美国FDA 指导原则 CVM GFI 141(VICH GL28)在人类食品致癌性检测中评价兽药残留安全性的研究 英文原版.pdf

Contains Non-Binding Recommendations 141 Guidance for Industry Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing VICH GL28 FINAL GUIDANCE (This version of the guidance replaces the version that was made available in May 24, 2004. This guidance document has been revised to correct the contact information in regard to this document.) This final guidance is to ensure that the assessment of carcinogenic potential is appropriate to human exposure through residues of veterinary drugs in food. Comments and suggestions regarding the document should be submitted to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to . All comments should be identified with the Docket No. 2001D-0357. For questions regarding this document, contact the Division of Human Food Safety, Center for Veterinary Medicine, (HFV-150), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8211. U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine July 27, 2006 Page 1 Contains Non-Binding Recommendations VICH GL28 (SAFETY : CARCINOGENITICY) October 2002 For implementation at Step 7 - Final STUDIES TO EVALUATE THE SAFETY OF RESI