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.
You may also be interested in...
Senate Medical Innovation Bill: Will Slow, Small And Steady Win The Race?
Compared to House's 21st Century Cures package, Senate's Healthier Americans initiative is tiny, but if nothing else bills will lay important groundwork for user fee legislation.
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.