“Breakthrough” Review: FDA And Sponsors Discuss Ways To Improve Efficiency
Pharmacyclics exec says PDUFA V “program” meetings should be optional, as timelines for mid-cycle communication and late-cycle meeting are out of sync with highly compressed review times for some products. CDER is internally discussing whether it would be feasible to give breakthrough therapy sponsors a target date for approval.
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Gottlieb Promotes 'Bottom-Up' Review To Increase FDA Efficiency, Consistency
US FDA commissioner nominee suggests breakthrough concepts should be more widely adopted within the review divisions and that staff should find and distribute best practices.
PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications
Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.
FDA ‘Expedited Review’ Would Shave Off Additional Month For Some ‘Breakthrough’ Products
FDA appears to be establishing new regulatory paradigm – albeit one that is not laid out in statute officially.