Business · 27/10/2014

FDA Releases Draft Guidance on Qualification of Galactomannan Biomarker for Invasive Aspergillosis Clinical Trials

The Food and Drug Administration (FDA) has made available a draft guidance for industry that outlines the use of Galactomannan detection in serum and/or bronchoalveolar lavage fluid to classify patients with probable invasive Aspergillosis for enrollment in clinical trials, as part of the Center for Drug Evaluation and Research's Drug Development Tool (DDT) Qualification Program.