Zdrowie i gospodarka · 07/07/2015

FDA Announces Draft Guidance for Biomarker-Plasma Fibrinogen in COPD Studies

The US Food and Drug Administration (FDA) has released a draft guidance for industry on the qualification of plasma fibrinogen as a biomarker in clinical trials for patients with chronic obstructive pulmonary disease (COPD), allowing drug developers to use it in new drug applications without additional review.