Zdrowie i gospodarka · 13/09/2016

FDA Announces Guidance for Industry on Biomarker Qualification for COPD Patients

The FDA has released a guidance document outlining the qualified use of plasma fibrinogen as a biomarker in clinical trials for patients with chronic obstructive pulmonary disease (COPD) at high risk of exacerbations and/or all-cause mortality, allowing drug developers to submit investigational new drug applications without additional review.