FDA's Stem Cell Oversight Faces Pivotal Test In DC Circ.
Law360, New York (October 22, 2013, 8:46 PM EDT) -- The D.C. Circuit is poised to shape the future of stem cell therapy as it mulls the extent of the U.S. Food and Drug Administration's power to regulate the potentially revolutionary field, likely determining whether numerous treatments can avoid costly and time-consuming approval processes, experts say.
At oral arguments this week, judges have seemed skeptical of the appeal from Regenerative Sciences LLC, a Colorado clinic accusing the FDA of improperly trying to police the practice of medicine by declaring its stem cell injections to be a drug instead of a procedure.
Few rulings appear to exist on the subject, and given...
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