FDA Finalizes Guidance on Deviation Reporting for HCT/Ps
By Zachary Brennan -
Published 06 September 2017
The US Food and Drug Administration (FDA) on Wednesday finalized guidance to help manufacturers of non-reproductive human cells, tissues and cellular and tissue-based products (HCT/Ps) understand the agency’s recommendations and relevant examples for complying with the requirements to investigate and report HCT/P deviations.
Categories: News, US, FDA, Biologics and biotechnology, Human cell and tissue
Tags: HCT/Ps, human tissues, FDA final guidance