用于安全与有效性研究的原始数据_中英文版
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#287
Raw Data for Safety and Effectiveness
Studies
Guidance for Industry
Submit comments on this guidance at any time. Submit electronic comments to
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments
should be identified with docket number FDA-2024-D-1613.
For further information regarding this document, contact AskCVM@fda.hhs.gov.
Additional copies of this guidance document may be requested from the Policy and Regulations
Staff, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place,
Rockville MD 20855, and may be viewed on the Internet at https://www.fda.gov/animal-
veterinary, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or
https://www.regulations.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine (CVM)
June 2025
#287
行业安全性与有效性研究指导原则的
原始数据
https://www.regulations.gov可随时提交对本指南的意见。电子意见提交至 。书面意见提
交至美国食品药品监督管理局档案管理工作人员，地址：5630 Fishers Lane，Rm. 1061，
Rockville，MD 20852。所有意见均应注明案卷号FDA-2024-D-1613。
AskCVM@fda.hhs.gov
如需了解有关本文件的更多信息，请联系 。
https://www.fda.gov/animal-
https://www.regulations.gov
本指南文件的其他副本可向美国食品药品监督管理局兽医中心政策和法规人员索取，地
址 为 7500 Standish Place，Rockville MD 20855， 也 可 在
veterinary，https://www.fda.gov/regulatory-information/search-fda-guidance-documents，or
上查阅。
美国卫生与公众服务部
美国食品药品监督管理局
兽医中心（CVM）
2025年6月
Contains Nonbinding Recommendations
Table of Contents
I. Introduction .......................................................................................................................... 1
II. Background .......................................................................................................................... 1
III. Purpose of CVM’s Review of Raw Data ............................................................................ 3
IV. How to Submit Raw Data .................................................................................................... 3
i
摘要：
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#287RawDataforSafetyandEffectivenessStudiesGuidanceforIndustrySubmitcommentsonthisguidanceatanytime.Submitelectroniccommentstohttps://www.regulations.gov.SubmitwrittencommentstotheDocketsManagementStaff,FoodandDrugAdministration,5630FishersLane,Rm.1061,Rockville,MD20852.Allcommentsshouldbeidentified...
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作者：薛定谔的龙猫
分类：专业资料
价格：50质量币
属性：10 页
大小：605.79KB
格式：PDF
时间：2025-11-12
