CBER (US Center for Biologics Evalation and Research) starts new programme to speed device approvals
This article was originally published in Clinica
Executive Summary
Device companies need no longer fear that their review applications will get held up at the US FDA's Center for Biologics Evaluation and Research (CBER). From August 2, each device application will be assigned a CBER facilitator to shepherd it through the premarket process, according to Lillian Yin, special advisor to the centre's director.