Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges
Journal of Law, Medicine & Ethics 38 (2):277-285 (2010)
This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases
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References found in this work BETA
Off-Label Prescribing: A Call for Heightened Professional and Government Oversight.Rebecca Dresser & Joel Frader - 2009 - Journal of Law, Medicine & Ethics 37 (3):476-486.
Off-Label Prescribing: A Call for Heightened Professional and Government Oversight.Rebecca Dresser & Joel Frader - 2009 - Journal of Law, Medicine and Ethics 37 (3):476-486.
Ethics and Innovation in Medicine.George J. Agich - 2001 - Journal of Medical Ethics 27 (5):295-296.
Citations of this work BETA
Embryo Stem Cell Research: Ten Years of Controversy.John A. Robertson - 2010 - Journal of Law, Medicine & Ethics 38 (2):191-203.
Overseeing Innovative Therapy Without Mistaking It for Research: A Function-Based Model Based on Old Truths, New Capacities, and Lessons From Stem Cells.Patrick L. Taylor - 2010 - Journal of Law, Medicine & Ethics 38 (2):286-302.
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