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In Brief: Skin replacements get expedited review

This article was originally published in The Gray Sheet

Executive Summary

Skin replacements get expedited review: Organogenesis' Graftskin receives FDA notice that its planned premarket approval application for treatment of venous ulcers will receive expedited review by the agency, the firm says. Organogenisis plans to submit the PMA "shortly." Advanced Tissue Sciences' Dermagraft Transitional Covering PMA also will receive expedited review, the firm announces. The submission will follow successful completion of an ongoing 65 patient pivotal clinical trial for treatment of burn patients...
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