美国FDA 指导原则 CVM GFI217抗球虫药物在食用动物中的效果 英文原版.pdfVIP

Contains Nonbinding Recommendations # 217 Guidance for Industry Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals (This guidance #217 will supersede the CVM draft Guidance for Industry #40, entitled “Draft Guideline for the Evaluation of The Efficacy of Anticoccidial Drugs and Anticoccidial Drug Combinations in Poultry,” dated April 1992.) Submit comments on this guidance at any time. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments on the guidance at . All written comments should be identified with the Docket No. FDA-2011-D-0784. For further information regarding this document, contact Emily R. Smith, (HFV-135), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 240-276-8344, e-mail: emily.smith2@. Additional copies of this guidance document may be requested from the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855 and may be viewed on the Internet at either /AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndust ry/default.htm or . U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine November 2012 Page 1 Contains Nonbinding Recommendations Table of Contents Introduction 4 I. General Considerations 5 A. Protocol Development 5 B. Animal Welfare Cons