CBER Director Marks: Regenerative Medicine Enforcement Will Be 'Notched Up' In 2018
In an interview with the Pink Sheet, Marks said the guidances on regenerative medicines make clear what the agency will be enforcing.
You may also be interested in...
Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.
Entities that already have received letters from the agency raising concerns about marketing unapproved products may not necessarily be the first to face enforcement actions, CBER official says.
US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period.