FocusRegulatory Science

FDA Oversight of Cell Therapy Clinical Trials

Science Translational Medicine  29 Aug 2012:
Vol. 4, Issue 149, pp. 149fs31
DOI: 10.1126/scitranslmed.3004131

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Abstract

The U.S. Food and Drug Administration applies regulatory flexibility to balance benefits and risks to subjects in cell-therapy clinical trials.

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