Cohera’s surgical sealant to be fast-tracked via new US FDA program
This article was originally published in Clinica
Cohera Medical’s Sylys Surgical Sealant is to be fast-tracked for US FDA approval, after being picked by the agency to go through the new Expedited Access Pathway. The program offers the prospect of using an interim clinical trial analysis as a way to kickstart premarket approval review and accelerate final approval for the device, among other benefits.
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