FDA oversight of cell therapy clinical trials

Sci Transl Med. 2012 Aug 29;4(149):149fs31. doi: 10.1126/scitranslmed.3004131.

Authors

Patrick Au¹, Deborah A Hursh, Agnes Lim, Malcolm C Moos Jr, Steven S Oh, Bruce S Schneider, Celia M Witten

Affiliation

¹ Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, MD 20852, USA. [email protected]

PMID: 22932219
DOI: 10.1126/scitranslmed.3004131

Abstract

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

MeSH terms

Biological Therapy* / adverse effects
Biological Therapy* / standards
Cell Transplantation / adverse effects
Cell Transplantation / legislation & jurisprudence*
Cell Transplantation / standards
Clinical Trials as Topic / legislation & jurisprudence*
Clinical Trials as Topic / standards
Evidence-Based Medicine / legislation & jurisprudence
Government Regulation*
Health Policy*
Humans
Patient Safety / legislation & jurisprudence*
Patient Safety / standards
Research Design / legislation & jurisprudence*
Research Design / standards
Risk Assessment
Risk Factors
Treatment Outcome
United States
United States Food and Drug Administration / legislation & jurisprudence*
United States Food and Drug Administration / standards