Development of a regulatory strategy for the cellular therapies: An American perspective

Materials Science and Engineering C

Volumn 13, Issue 1-2, 2000, Pages 15-17

  Du Moulin, Gary C ^a   Morohashi, Michiaki ^a,b  

^a GENZYME CORPORATION   (United States)

^b Genzyme   (Japan)

Author keywords

Autologous chondrocyte implantation; Cellular therapies; Genzyme Tissue Repair

Indexed keywords

BIOTECHNOLOGY; ENZYMES; HEALTH RISKS; LAWS AND LEGISLATION; PUBLIC POLICY; PUBLIC RISKS; RISK ASSESSMENT; RISK MANAGEMENT; TECHNOLOGY TRANSFER;

CELLULAR THERAPY;

TISSUE CULTURE;

EID: 0040364108     PISSN: 09284931     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0928-4931(00)00171-5     Document Type: Article

References (3)

1. Center for Biologics, Evaluation and Research, Points to consider in the collection, processing, and testing of ex vivo activated mononuclear leukocytes for administration to humans, Aug. 22, 1989, Food and Drug Adminstration, Rockville, MD, 1989.
2. Arnow P.M., Houchins S.G., Richards J.M., Chudy R. Aspergillus fumigatus contamination of lymphokine activated killer cells infused into cancer patients. J. Clin. Microbiol. 29(5):1991;1038-1041.
3. Center for Biologics, Evaluation and Research, Proposed approach to regulation of cellular and tissue based products. Docket No. 97N-0668 28 February, Food and Drug Adminstration, Rockville, MD, 1997.