Inside FDA’s Debates On ‘Breakthrough’

Office of New Drugs Director Jenkins provides a peek into the Medical Policy Council’s efforts to consistently interpret and implement the ‘breakthrough therapy’ program.

All “breakthrough therapy” designation requests for products regulated by the Center for Drug Evaluation and Research are evaluated by the center’s Medical Policy Council.

The council provides a senior-level forum for establishing medical policy in the center and ensuring consistent application across review divisions Also see "CDER Medical Policy Council Balances “Breakthrough” Requests...

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