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  • Regulatory NewsRegulatory News

    CBER: Most Frequently Reported HCT/P Deviations

    For manufacturers of non-reproductive human cells, tissues, and cellular and tissue-based products (HCT/Ps), FDA released draft guidance on Wednesday outlining the most frequently reported HCT/P deviations reported to the Center for Biologics Evaluation and Research (CBER). Under FDA’s authority, a manufacturer of non-reproductive HCT/Ps must investigate and report to the agency all HCT/P deviations related to a distributed product for which the establishment performed a...