GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’
This article was originally published in The Pink Sheet Daily
Negotiations for generic drug user fee reauthorization open with FDA saying it doesn't want a large number of small tweaks that will increase program complexity.
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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.