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GUIDANCE DOCUMENT

Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry September 2016

Final

Qualification of Biomarker Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients With Chronic Obstructive Pulmonary Disease Guidance for Industry

Docket Number:
FDA-2015-D-2244
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Contains Nonbinding Recommendations


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All written comments should be identified with this document's docket number: FDA-2015-D-2244.