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. 2014 Aug;32(8):721-3.

doi: 10.1038/nbt.2971.

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

Alexander M Bailey¹, Michael Mendicino², Patrick Au¹

Affiliations

Affiliations

¹ FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA.
² 1] FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA. [2] FDA, Office of Commissioner, Office of Chief Scientist, Office of Regulatory Science and Innovation, Silver Spring, Maryland, USA. [3] Mesoblast Inc., New York, New York, USA.

PMID: 25093890
DOI: 10.1038/nbt.2971

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

Alexander M Bailey et al. Nat Biotechnol. 2014 Aug.

. 2014 Aug;32(8):721-3.

doi: 10.1038/nbt.2971.

Authors

Alexander M Bailey¹, Michael Mendicino², Patrick Au¹

Affiliations

¹ FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA.
² 1] FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA. [2] FDA, Office of Commissioner, Office of Chief Scientist, Office of Regulatory Science and Innovation, Silver Spring, Maryland, USA. [3] Mesoblast Inc., New York, New York, USA.

PMID: 25093890
DOI: 10.1038/nbt.2971

No abstract available

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References

1. Sci Transl Med. 2012 Aug 15;4(147):147fs28 - PubMed
1. Cell Stem Cell. 2014 Feb 6;14(2):141-5 - PubMed

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