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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