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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

Final

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

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.