FDA Alzheimer’s Disease Developing Drugs for Treatment Guidance for Industy
标准简介
Alzheimer’s Disease Developing Drugs for Treatment Guidance for Industy[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Alzheimer’s Disease Developing Drugs for Treatment Guidance for Industy[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Draft — Not for Implementation 1 Early Alzheimer’s Disease: 2 Developing Drugs for Treatment 1
3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person 10 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 11 requirements of the applicable statutes and regulations. To discuss an alternative approach, 12 contact the FDA staff responsible for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 The purpose of this guidance is to assist sponsors in the clinical development of drugs for the 20 treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt 21 dementia (collectively referred to as early AD in this guidance, though it is recognized that 22 patients with later stage early AD and patients with AD in the earliest stages of dementia may 2
23 not differ significantly). This guidance is intended to serve as a focus for continued discussions 24 among representatives of the Division of Neurology Products in the Center for Drug Evaluation 25 and Research or the Office of Tissues and Advanced Therapies (OTAT) in the Center for 26 Biologics Evaluation and Research, as appropriate, pharmaceutical sponsors, the scientific 3
27 community, and the public. The design of clinical trials that are specifically focused on the 28 treatment of patients with AD who have developed overt dementia, or any of the autosomal 29 dominant forms of AD, is not discussed, although some of the principles in this guidance may be 30 pertinent. 31 32 This guidance revises the draft guidance for industry Alzheimer’s Disease: Developing Drugs 33 for the Treatment of Early Stage Disease issued in February 2013. This revision addresses the 34 Food and Drug Administration’s (FDA’s) current thinking regarding the selection of patients 35 with early AD for enrollment into clinical trials and the selection of endpoints for clinical trials 36 in these populations. 1
This guidance has been prepared by the Division of Neurology Products in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products unless otherwise specified. 3
In addition to consulting guidances, sponsors are encouraged to contact the Division of Neurology Products or OTAT to discuss specific issues that arise during the development of drugs to treat early AD.
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