Fibrocell Science, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma—a chronic, debilitating genetic skin disorder with no FDA approved therapies. 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. Previously, the FDA granted Orphan Drug Designation to FCX-013 for the treatment of localized scleroderma and Rare Pediatric Disease Designation for the treatment of moderate to severe localized scleroderma. In addition, Fibrocell is developing FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), which is currently under evaluation in the Phase 2 portion of a Phase 1/2 clinical trial.  FDA previously granted Orphan Drug, Rare Pediatric Disease and Fast Track Designations to FCX-007.