Breakthrough Designation Can Be 'Lever' For Manufacturing Evolution, FDA Says

CDER Director Woodcock notes breakthrough program often pushes sponsors to modernize production processes.

FDA's breakthrough therapies program has been lauded for helping get game-changing therapies to market faster. In the process it also may help industry modernize its manufacturing systems.

Much of the program's success centers on its promise of increased agency involvement for therapies showing the potential to become...

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