Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the important provisions of the new prescription drug and generic drug user fee commitment letters (:53), including the revenue cut coming in PDUFA VIII (7:16), as well as the new formal meeting names (13:53) and “America First” incentives (23:47) in GDUFA IV.

More On These Topics From The Pink Sheet

US FDA Will Start PDUFA VIII Collecting Less Revenue, But Will Fees Drop?: insights.citeline.com/pink-sheet/pathways-and-…

Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: insights.citeline.com/pink-sheet/biosimilars-a…

Generic Drug User Fee Agreement Streamlines Meetings,
Creates ‘Complex Issue’ Goal Extension: insights.citeline.com/pink-sheet/biosimilars-a…