Looking ahead for Dermagraft

Looking ahead for Dermagraft

WASHINGTON - Last week's positive FDA advisory committee meeting for Advanced Tissue Sciences Inc.'s Dermagraft-TC, a temporary covering for severe burns, sets the stage for what could be a more complex discussion of ATIS's next product, Dermagraft for diabetic foot ulcers. It also broke ground for consideration of engineered tissue from other companies, including Organogenesis Inc. (ORG, Canton, Mass.).

ATIS and the General and Plastic Surgery Devices Panel broke new ground last week by evaluating the safety and efficacy of the first cell-based medical device (see BioCentury Extra Nov. 20). FDA officials, panel members and the company frankly acknowledged that there are no clearly delineated guidelines or standards for

Read the full 1126 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE