PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification
This article was originally published in The Pink Sheet Daily
But user fees would need to be significantly restructured to make up revenue if establishment fees were eliminated, or even just changed, as part of reauthorization.
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Fee structure changes and process enhancements floated during opening session between industry and agency.
Industry official sees potential for some streamlining in user fee program, but adding to breakthrough and patient-centered activities seems most likely.
Acting Commissioner Ostroff wonders if all aspects of user fee program are delivering maximum added value.