Hemophilia Accelerated Approval: Factor Activity Useful Surrogate, Panel Says

Variability in assays is important issue in managing patients at “trough” levels, experts at US FDA hemophilia workshop suggest. However, assuming some significant level of activity is restored, the exact level isn’t overly important. 

Hemophilia_525478450_1200.jpg

More from Approval Standards

More from Pathways & Standards