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

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.