‘Breakthrough’ Therapies: Information Requests A Sign Of Workload Problem?
FDA on average sent about 20 more information requests during breakthrough product reviews than others in the Program, according to interim assessment of the PDUFA V review system. Assessment could support higher funding for breakthrough program in next user fee round.
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Case studies demonstrating what kinds of drugs do and don’t qualify for the expedited pathway designation will be presented at an April workshop co-sponsored by the Brookings Institution.
Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.
Woodcock says FDA will manage breakthrough applications along with its entire portfolio of submissions, but some stakeholders express concern about whether the demands of the exceedingly popular program will affect the agency’s handling of other applications.