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The agency provides a qualified context of use for the biomarker plasma fibrinogen.
On Sept. 14, 2016, FDA published guidance providing a qualified context of use (COU) for plasma fibrinogen, a biomarker, in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality. According to FDA, “fibrinogen is an acute phase protein that is elevated in inflammation. It is a soluble plasma glycoprotein that is converted by thrombin to fibrin during blood clot formation.”
The experimental conditions and constraints for which this biomarker is qualified through the Center for Drug Evaluation and Research’s (CDER) Biomarker Qualification Program are also described. The guidance states that drug developers may use plasma fibrinogen “for the qualified COU in submissions of investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker.” FDA states that the use of the biomarker outside of the qualified COU will be considered on a case-by-case basis and more information regarding the expanded use may be required.