FDA Chronic Obstructive Pulmonary Disease Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool
标准简介
Chronic Obstructive Pulmonary Disease Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool[附网盘链接]是Food&Drug Administration于过去发布的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 Obstructive Pulmonary Disease Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool[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
Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool 1
Guidance for Industry This guidance represents 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 office responsible for this guidance as listed on the title page. I. INTRODUCTION AND BACKGROUND • The purpose of this guidance is to provide information to sponsors developing drugs for 2
the treatment of chronic obstructive pulmonary disease (COPD). This guidance addresses the use of the St. George’s Respiratory Questionnaire (SGRQ), a patient-
reported outcome measure (PRO) assessment tool used in interventional clinical trials in patients with COPD. • The information on SGRQ presented in this guidance was previously provided in an appendix to the draft guidance for industry Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment, which published in May 2016 and was subsequently withdrawn for reasons unrelated to the subject of this guidance. • 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. • COPD is a chronic progressive disease caused by chronic inflammation and destruction of the airways and lung parenchyma and is usually associated with tobacco smoking or prolonged exposure to other noxious particles and gases. The term COPD encompasses a 1
This guidance has been prepared by the Division of Pulmonary, Allergy, and Rheumatology Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (available at https://www.regulations.gov/docket?D=FDA-2017-D-6821) (see the instructions for submitting comments in the docket). 2
For the purposes of this guidance, all references to drugs include both human drugs and therapeutic biological products, including small and large molecule drugs, unless otherwise specified. 1
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