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CBER Director Marks: Regenerative Medicine Enforcement Will Be 'Notched Up' In 2018

 
• By Michael Cipriano

In an interview with the Pink Sheet, Marks said the guidances on regenerative medicines make clear what the agency will be enforcing.

Cracking the whip against bad actors in the regenerative medicines arena, such as noncompliant stem cell clinics, has always been a priority for the Center for Biologics Evaluation and Research (CBER). But the center plans on taking its enforcement actions a step further in 2018, CBER Director Peter Marks says.

"Enforcement actions on stem cell clinics that were putting out products that could put patients at risk that were unapproved stem cell products was a priority," Marks said in an exclusive interview with the Pink Sheet

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