title: An FDA perspective on preclinical development of cell-based regenerative medicine products.
authors.affiliation: FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Bailey
authors.affiliation: 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Mendicino
authors.affiliation: FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA.
authors.forename: Patrick
authors.initials: P
authors.lastname: Au
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D044968:Regenerative Medicine; D014481:United States; D014486:United States Food and Drug Administration
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references.pmid: 22896673
references.citation: Cell Stem Cell. 2014 Feb 6;14(2):141-5
references.pmid: 24506881