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…