FDA CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals
标准简介
CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals[附网盘链接]是于不久前发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为CVM GFI #217 Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
EVALUATING THE EFFECTIVENESS OF ANTICOCCIDIAL DRUGS IN FOOD-PRODUCING ANIMALS This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. Introduction This guidance provides recommendations to industry relating to study design and describes criteria that the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs in poultry and other food-producing animals. Section I discusses general considerations regarding the development of protocols, study conduct, animal welfare, substantial evidence of effectiveness, feed preparation, nutritional content of experimental diets, and the assessment of drug concentrations in experimental diets. Section II discusses the studies CVM recommends to substantiate effectiveness of an anticoccidial drug in poultry. Sections III and IV provide information regarding the development of studies to demonstrate the effectiveness of anticoccidials for minor uses and minor species and the effectiveness of anticoccidials in food-producing mammals, respectively. The guidance is not a comprehensive source of information on conducting clinical effectiveness studies. Alternative study designs for providing substantial evidence of effectiveness may be acceptable. Sponsors should contact CVM to discuss their development plan prior to initiating any studies. Sponsors and clinical investigators should consult the Code of Federal Regulations (21 CFR Parts 511 and 514) for information on the proper shipment, use, and disposition of investigational new animal drugs, as well as submission of the results of clinical investigations. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required.
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