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References
United States Code Title 21, Section 312.23(a)(8) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.23.
Bailey, A.M. Sci. Transl. Med. 4, 147fs28 (2012).
Mendicino, M., Bailey, A.M., Wonnacott, K., Puri, R.K. & Bauer, S.R. Cell Stem Cell 14, 141–145 (2014).
Anatol, R. et al. The regulatory process from concept to market. Principles of Tissue Engineering 1781–1797 (Academic Press, 2013).
Robinson, R., Bailey, A.M. & Ibrahim, S. Sci. Transl. Med. 3, 94ec124 (2011).
Acknowledgements
We thank C. Gacchina Johnson for her contributions to data analysis of regulatory submissions.
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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). https://doi.org/10.1038/nbt.2971
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DOI: https://doi.org/10.1038/nbt.2971
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