From bench to FDA to bedside: US regulatory trends for new stem cell therapies

Advanced Drug Delivery Reviews

Volumn 82, Issue , 2015, Pages 192-196

  Knoepfler, Paul S ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b SHRINERS HOSPITALS FOR CHILDREN NORTHERN CALIFORNIA   (United States)

Author keywords

Compassionate use; FDA; Homologous use; Regenerative medicine; Right to try laws; Stem cell treatments; Stem cells

Indexed keywords

CYTOLOGY; DRUG PRODUCTS; LAWS AND LEGISLATION; PRODUCT DEVELOPMENT; REGENERATIVE MEDICINE;

COMPASSIONATE USE; FOOD AND DRUG ADMINISTRATION; HOMOLOGOUS USE; REGULATORY AUTHORITIES; REGULATORY OVERSIGHT; REGULATORY PATHWAY; RIGHT TO TRY LAWS; STEM CELL THERAPY;

STEM CELLS;

ADULT STEM CELL; BIOLOGICAL THERAPY; COMPASSIONATE USE; EMBRYONIC STEM CELL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HUMAN; LAW; MEDICAL TOURISM; PLURIPOTENT STEM CELL; PRIORITY JOURNAL; PRODUCT DEVELOPMENT; REGENERATIVE MEDICINE; REVIEW; STEM CELL TRANSPLANTATION; UNITED STATES; LEGISLATION AND JURISPRUDENCE; PATIENT RIGHT; TRANSLATIONAL RESEARCH;

BIOLOGICAL PRODUCT;

BIOLOGICAL PRODUCTS; COMPASSIONATE USE TRIALS; HUMANS; MEDICAL TOURISM; PATIENT RIGHTS; REGENERATIVE MEDICINE; STEM CELL TRANSPLANTATION; TRANSLATIONAL MEDICAL RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84927164105     PISSN: 0169409X     EISSN: 18728294     Source Type: Journal    
DOI: 10.1016/j.addr.2014.12.001     Document Type: Review

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