ReCell regulatory update

Avita said FDA’s Center for Biologics Evaluation and Research (CBER) granted Expedited Access Pathway (EAP) designation to ReCell to treat burns. The EAP program seeks to grant expedited development, assessment and review to medical devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Avita expects to determine a new timeline for FDA approval of ReCell following discussion with the agency. Previously, the company said it had estimated approval in 3Q17. ...