Fibrocell Science, Inc. announced that the U. S. Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007, the company’s clinical-stage candidate for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)—a rare, devastating genetic skin disease for which no FDA-approved therapies exist. The Fast Track program is designed to facilitate development and expedite review of new therapies that address unmet medical needs of patients with serious conditions. The designation offers various benefits, including more frequent meetings with the FDA to discuss the drug's development plan, eligibility for Accelerated Approval or Priority Review if relevant criteria are met, and opportunity for Rolling Review, which allows the Company to submit completed sections of its Biologics License Application (BLA) to the FDA, rather than waiting until every section of the BLA is completed before the entire application can be reviewed. FCX-007 was previously granted Orphan Designation by the FDA for the treatment of Dystrophic Epidermolysis Bullosa (DEB), which includes RDEB, and Rare Pediatric Disease Designation by the FDA for treatment of RDEB.