Fed­er­al judge rules against FDA in ma­jor stem cell over­sight case

A Cal­i­for­nia judge yes­ter­day sided with a stem cell clin­ic chain against the FDA, set­ting shock waves through the agency as it po­ten­tial­ly has to re­work how it en­forces these clin­ics mov­ing for­ward.

Judge Je­sus Bernal ruled in fed­er­al court in Cal­i­for­nia’s Cen­tral Dis­trict against the FDA’s ar­gu­ment that a group of stem cell clin­ics called the Cell Sur­gi­cal Net­work, led by Mark Berman and El­liot Lan­der, were sell­ing un­ap­proved drug prod­ucts in the form of adi­pose, or fat, cell mix­tures.

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