D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies
05 February 2014Pharmaceutical 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.