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An FDA perspective on preclinical development of cell-based regenerative medicine products

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Figure 1: Characteristics of cell-based regenerative medicine products and preclinical testing programs, based on analysis of 163 IND submissions to the FDA/CBER/OCTGT from 2006 to 2013.


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We thank C. Gacchina Johnson for her contributions to data analysis of regulatory submissions.

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Correspondence to Alexander M Bailey, Michael Mendicino or Patrick Au.

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Bailey, A., Mendicino, M. & Au, P. An FDA perspective on preclinical development of cell-based regenerative medicine products. Nat Biotechnol 32, 721–723 (2014).

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