US considers biologics centre as tissue oversight body
This article was originally published in Clinica
While industry is battling for an FDA reform bill that would remove all devices from the regulatory scope of the Center for Biologics Evaluation and Research (CBER), known locally as the devices centre, the FDA is considering whether tissue-engineered skin should be put under the centre's authority. The issue has commercial implications, as it is claimed that successful development and marketing of these products may be slowed by uncertainty about their jurisdiction.
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