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# Guidance on Plasma Fibrinogen Biomarker Qualification
- URL: https://www.fdaweb.com/guidance-on-plasma-fibrinogen-biomarker-qualification/
- Published: 2016-09-13T12:00:00.000Z
- Updated: 2026-09-14T21:31:09.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136793

*Federal Register* notice: FDA has released a guidance on “Qualification of Biomarker — Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Patients With Chronic Obstructive Pulmonary Disease (COPD).” The document provides a qualified context of use for plasma fibrinogen in COPD interventional clinical trials for patients at high risk for exacerbations or all-cause mortality. To view this guidance, click [here](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-13/pdf/2016-21964.pdf?ref=fdaweb.com).