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GUIDANCE DOCUMENT

Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool Guidance for Industry March 2018

Download the Final Guidance Document
Final
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to provide information to sponsors developing drugs for the treatment of chronic obstructive pulmonary disease (COPD).2 This guidance addresses the use of the St. George’s Respiratory Questionnaire (SGRQ), a patientreported outcome measure (PRO) assessment tool used in interventional clinical trials in patients with COPD.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6821.

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