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