Allowing innovative stem cell-based therapies outside of clinical trials: Ethical and policy challenges

Journal of Law, Medicine and Ethics

Volumn 38, Issue 2, 2010, Pages 277-285

  Hyun, Insoo ^a  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL (TOPIC); COMPASSIONATE USE; CONFERENCE PAPER; ETHICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE DELIVERY; HEALTH CARE POLICY; HUMAN; LEGAL ASPECT; MASS COMMUNICATION; MEDICAL TOURISM; OFF LABEL DRUG USE; PRACTICE GUIDELINE; PSYCHOLOGICAL ASPECT; REGENERATIVE MEDICINE; STATISTICS; STEM CELL TRANSPLANTATION; TRANSLATIONAL RESEARCH; UNITED STATES;

CLINICAL TRIALS AS TOPIC; COMPASSIONATE USE TRIALS; DIFFUSION OF INNOVATION; ETHICAL ANALYSIS; FEDERAL GOVERNMENT; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HEALTH POLICY; HEALTH SERVICES ACCESSIBILITY; HUMANS; MEDICAL TOURISM; OFF-LABEL USE; REGENERATIVE MEDICINE; STEM CELL TRANSPLANTATION; TRANSLATIONAL MEDICAL RESEARCH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77954901724     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2010.00488.x     Document Type: Conference Paper

References (25)

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12. This critique also assumes too narrow of a view. Interventions that are not FDA-approved might still be offered overseas, and to shrug off any further discussion of stem cell-based innovative therapies based on current FDA standards would be to advance a U.S.-centric response to the international problem of stem cell tourism, much of which involves American patients traveling abroad. The question of whether and how to regulate stem cell-based innovative therapies is an issue for all countries, not just the U.S. Furthermore, as I argue in this section, the thorny issues raised in this essay cannot be resolved simply by depending on current American regulations.
13. 21 C.F.R. § 312 and § 316 (2009), at 40900.
14. at 40899 and 40900
15. at 40906, my brackets
16. at 40921
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