CDER Medical Policy Council Balances “Breakthrough” Requests With Broader Issues
FDA is seeking public input on cross-cutting policy issues to bring before the senior-level group, which is also facing the challenge of reviewing dozens of “breakthrough therapy” designation requests relevant to CDER-regulated products.
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CDER’s Woodcock says accelerated approval requirements in 21st Century Cures legislation could create a process akin to how FDA handles breakthrough designations.
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.