5 Lessons Doctors Can Take From FDA's Big Stem-Cell Win
Law360, New York (February 7, 2014, 7:22 PM EST) -- The D.C. Circuit on Tuesday delivered a loud wake-up call to stem cell clinics when it endorsed strong oversight by the U.S. Food and Drug Administration, but doctors can take comfort in a number of exceptions and strategies that could limit the ruling's reach.
At issue were treatments by Colorado-based Regenerative Sciences LLC that involve extracting cells and letting them multiply in a laboratory setting — a process the appeals court said crossed the line into drug manufacturing, triggering FDA scrutiny. That's a costly setback for clinics, but there is reason to believe they'll find ways around the decision by moving...
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