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Zdrowie i gospodarka · 13/09/2021

FDA Consolidates Oversight of Devices Processing Autologous Human Cells for Therapeutic Use

The FDA is transferring regulatory oversight of certain devices processing autologous human cells, tissues, and products at the point of care to the CBER, affecting only center assignment, as part of a consolidation effort to support the production of therapeutic articles.

Source: Federal Register — Food and Drug AdministrationOpen original release →