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In this section: Search for FDA Guidance Documents

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

Docket Number:: FDA-2015-D-2244
Issued by:: Guidance Issuing Office

Center for Drug Evaluation and Research

Contains Nonbinding Recommendations

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

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

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-2015-D-2244.

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