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FDA's Office CBER Publishes Q&As on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
This document pays tribute to the comments CBER received to the interim final rule, published on May 25, 2005. After reviewing those comments FDA published the final rule without changes. It became effective immediately (June 19, 2007). But CBER decided to release its position to certain questions with the aim to provide a quick reference to the provisions.
The questions which are discussed in the Q&A document focus on donor screening and testing and related labelling.
The points discussed are:
Find CBER's answers to these questions at
You may download the pdf version of the final final rule
Human Cells, Tissues, and Cellular and Tissue-Based Products are becoming more and more important for industry. Please let us know if you are interested in this new topic in order to consider this development for the future planning. Please send an E-Mail to info (at) gmp-compliance (dot) org if you are interested in this topic.