Plasma Fibrinogen Biomarker Guidance

FDA has published a guidance, Qualification of Biomarker—Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality in Patients with Chronic Obstructive Pulmonary Disease, to provide a qualified context of use for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease at high risk for exacerbations and/or all-cause mortality. The guidance also describes the experimental conditions and constraints for which the biomarker is qualified through the CDER Biomarker Qualification Program.

“This biomarker can be used by drug developers for the qualified COU in submissions of INDs, NDAs, and BLAs without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker,” the guidance says. “It does not change any regulatory status, decisions, or labeling of any in vitro diagnostic test used in the medical care of patients.”