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PDUFA Budgeting: What Will Get Added, Subtracted – Or Multiplied By Cures?

This article was originally published in The Pink Sheet Daily

Executive Summary

Industry official sees potential for some streamlining in user fee program, but adding to breakthrough and patient-centered activities seems most likely.

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PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification

User fees would need significant restructuring to make up revenue if establishment fees are eliminated, or even just changed, as part of reauthorization. As part of FDA-industry negotiations, several small working groups are expected to be created to deal with specific issues.

PDUFA VI Might Adjust Establishment Fees; FDA Aims For Simplification

User fees would need significant restructuring to make up revenue if establishment fees are eliminated, or even just changed, as part of reauthorization. As part of FDA-industry negotiations, several small working groups are expected to be created to deal with specific issues.

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