FDA CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
标准简介
CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs[附网盘链接]是于过去发布的FDA标准，适用于美国。标准截图
![CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs[附网盘链接]](/img/20210914103704iq67w.jpg)
标准文档说明
标准文档类型为CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs[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
Draft — Not for Implementation Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs Draft Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. Introduction FDA is issuing this draft Guidance for Industry (GFI), as required under section 305 of the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (Pub. L. 115-234), to assist sponsors in incorporating real-world evidence (including ongoing surveillance activities, 1
observational studies, and registry data) into proposed clinical investigation protocols and applications for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 305 of Pub. L. 115-234, among other things, directed FDA to hold a public meeting for interested parties to discuss innovative animal drug investigation designs and to issue guidance addressing the incorporation of the use of such elements of investigations as complex adaptive and other novel investigation designs, data from foreign countries, real-world evidence (including ongoing surveillance activities, observational studies, and registry data), biomarkers, and surrogate endpoints into clinical investigation protocols and applications to support the effectiveness of new animal drugs. In general, FDA’s guidance documents 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. II. Background In the Federal Register of July 9, 2019 (84 FR 32749), FDA’s Center for Veterinary Medicine (CVM) published a notice of a public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs” giving interested persons until August 17, 2019, to comment on the topics discussed at the public meeting and the questions published in the 1
Submission of protocols is not required; however, it is recommended for any study intended to support the approval or conditional approval of a new animal drug.
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