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Progenitor and Stem Cell Technologies and Therapies by A Atala

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8

Regulatory considerations of stem and progenitor cell-based products: US Food and Drug Administration

D.W. Fink, S.R. Bauer, P. Au, C.C. Haudenschild, M.H. Lee and B.K. McCright,     Center for Biologics Evaluation and Research, US-FDA, USA

Abstract:

This chapter focuses on US Food and Drug Administration (FDA) regulatory considerations for stem/progenitor cell-based products (S/PCPs) intended to treat, mitigate or cure disease. Information critical to the regulatory decision-making process for determining the safety and efficacy of investigational S/PCPs is described. Included are sections that cover cellular product manufacturing and characterization, preclinical testing and clinical trial design. Increased regulatory complexity associated ...

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