Abstract
Correspondence to: Michele Keane-Moore, Center for Biologics Evaluation and Research, FDA, 1401 Rockville Pike, Rockville, MD 20852-1448, USA. In 1997 the US Food and Drug Administration (FDA) proposed a new regulatory framework for human cellular and tissue-based products, including hematopoietic stem cells, in two documents entitled Reinventing the regulation of human tissue [1] and A proposed approach to the regulation of cellular and tissue-based products [2]. The proposed framework provided a tiered approach to the regulation of cellular and tissuebased products, now referred to as human cells, tissues, and cellular and tissue-based products (HCT/Ps). The regulatory framework focused on three general areas:
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