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D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies

05 February 2014

Pharmaceutical and Biotechnology Alert

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States. Through its February 4 decision, the court has broadly upheld FDA's authority to regulate stem cell therapies as drugs. Thus, any sense that the development of such therapies may be exempt from the pre-market approval process, or from FDA’s labeling and manufacturing requirements, is now sorely misplaced.

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