Regenerative Medicine In Cures: Conditional Approval Dropped In Lieu Of ‘Breakthrough’-Style Approach

Push to open up new US pathway for regenerative medicine helped the 21st Century Cures bill make it to the finish line in the lame duck Congress – but only after the proposal has been dramatically revised to fit into the established BLA pathway.

pluripotent stem cell

The US FDA will be given broad discretion to shape new approaches to regenerative medicine under the “21st Century Cures” bill heading towards enactment next week.

The inclusion of language to govern the regulation of regenerative medicine is one of the most important changes to the bill from the version that passed the House in 2015...

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