Examination of the regulatory frameworks applicable to biologic drugs (including stem cells and their progeny) in Europe, the U.S., and Australia: Part I-a method of manual documentary analysis

Stem Cells Translational Medicine

Volumn 1, Issue 12, 2012, Pages 898-908

  Ilic, Nina ^a,b   Savic, Snezana ^a   Siegel, Evan ^c   Atkinson, Kerry ^d,e   Tasic, Ljiljana ^a  

^a UNIVERSITY OF BELGRADE   (Serbia)

^b MATER HOSPITAL   (Australia)

^c Ground Zero Pharmaceuticals   (United States)

^d MATER MEDICAL RESEARCH INSTITUTE   (Australia)

^e UNIVERSITY OF QUEENSLAND   (Australia)

Author keywords

Cellular therapy; Clinical translation; Clinical trials; Ethics

Indexed keywords

BIOLOGICAL PRODUCT;

ARTICLE; AUSTRALIA; DOCUMENTATION; EUROPE; FOOD AND DRUG ADMINISTRATION; GENE THERAPY; HUMAN; LEGAL ASPECT; PRACTICE GUIDELINE; QUALITATIVE RESEARCH; SOMATIC CELL THERAPY; STEM CELL; UNITED STATES; ANIMAL; STANDARD; STEM CELL TRANSPLANTATION;

ANIMALS; AUSTRALIA; BIOLOGICAL AGENTS; DOCUMENTATION; EUROPE; HUMANS; STEM CELL TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

MLCS; MLOWN;

EID: 84872922024     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2012-0037     Document Type: Article

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