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GDUFA II: FDA Prefers A ‘Manageable Number of High-Impact Changes’

 
• By Derrick Gingery

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.

FDA wants to make significant, but feasible, changes to the generic drug user fee program as part of its reauthorization rather than too many small tweaks.

Agency officials told industry representatives during the first GDUFA II negotiating session that multiple small changes likely would complicate program...

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More from North America

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