BioCentury
ARTICLE | Politics & Policy

FDA issues final guidance on COPD biomarker

September 12, 2016 7:00 AM UTC

FDA issued final guidance outlining its recommendations on the use of plasma fibrinogen as a prognostic biomarker for patients with chronic obstructive pulmonary disease (COPD) who are at high risk for exacerbation or mortality. The agency released draft guidance last year, and received no comments (see BioCentury Extra, July 7, 2015).

FDA said plasma fibrinogen can be used as a biomarker to enrich clinical trials for high-risk COPD patients under its qualifying conditions in INDs, NDAs and BLAs without confirmation by a review committee. ...