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Processed skin on fast track to approval

This article was originally published in Clinica

Executive Summary

The US FDA has notified Organogenesis (US) that its premarket approval application for the Graftskin manufactured human skin product will receive expedited review. The company plans to submit a PMA following further analysis of trial data (see Clinica No 655, p 19). The FDA says it believes "Graftskin has the potential to offer a viable alternative for treatment of chronic venous insufficiency ulcers".

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