GDUFA III: How Much Of A Fee Increase Can Industry Stomach?
Executive Summary
Amid questions about generic industry market dynamics, the user fee renewal could focus on limiting increases in US FDA collections.
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GDUFA III Agreement Will Constrain Fee Revenue Increases
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
GDUFA III Agreement Will Constrain Fee Revenue Increases
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
GDUFA III: US FDA Says Generic Drug Supplement Volume Could Require More Resources
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