ATS' DERMAGRAFT FOR DIABETIC ULCERS NEEDS RANDOMIZED POSTMARKET EFFICACY STUDY, PANEL SAYS JAN. 29; SKIN GRAFT APPROVAL SUPPORTED IN 7-2 VOTE
This article was originally published in The Gray Sheet
Executive Summary
Advanced Tissue Sciences' Dermagraft premarket approval application to use the bioengineered human skin graft in healing diabetic foot ulcers is approvable with two conditions, FDA's General and Plastic Surgery Devices panel recommended by a 7-2 vote at its Jan. 29 meeting in Gaithersburg, Maryland.