FDA Chronic Fatigue SyndromeMyalgic Encephalomyelitis Developing Drug Products for Treatment
标准简介
Chronic Fatigue SyndromeMyalgic Encephalomyelitis Developing Drug Products for Treatment[附网盘链接]是于之前发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Chronic Fatigue SyndromeMyalgic Encephalomyelitis Developing Drug Products for Treatment[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Draft — Not for Implementation 1 1 Guidance for Industry 2 Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing 3 Drug Products for Treatment 4 5 6 7 8 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current 9 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 10 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 11 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 12 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 13 the appropriate number listed on the title page of this guidance. 14 15 16 17 18 I. INTRODUCTION 19 20 This guidance is intended to assist sponsors in the development of drug products for the 2
21 treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This guidance 22 focuses on specific drug development and trial design issues that are unique to the study of 23 CFS/ME and on the FDA’s current thinking on how effective treatments can be developed for 24 CFS/ME. The points discussed in this guidance may not be applicable to all drug products. The 25 FDA encourages sponsors to design clinical programs that fit their particular needs and to 26 discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology 27 Products. 28 29 This guidance does not contain discussion of the general issues of statistical analysis, clinical 30 trial design, or patient-reported outcome (PRO) instruments. Those topics are addressed in the 31 ICH guidances for industry E9 Statistical Principles for Clinical Trials and E10 Choice of 32 Control Group and Related Issues in Clinical Trials and the guidance for industry Patient-
33 Reported Outcome Measures: Use in Medical Product Development to Support Labeling 3
34 Claims, respectively. This guidance does not address nomenclature considerations or 35 nonclinical development. 36 1
This guidance has been prepared by the Division of Pulmonary, Allergy, and Rheumatology Products in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 2
In this guidance, the term drug product includes all types of therapeutic agents, such as small and large molecule drugs, and therapeutic biological products, regulated within CDER. 3 We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 1
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