FDA’s Breakthrough Designations Face Question Of Review Resources
This article was originally published in The Pink Sheet Daily
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.
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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.
Members will enter data into secure database, allowing trade groups to gauge trends and problems with the PDUFA V application review program – and giving industry a stronger negotiating position for the next user fee round.
A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.