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?: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-will-start-pdufa-viii-collecting-less-revenue-but-will-fees-drop-3VJC34BDRZFHHMY5N5YIODQRZ4/ Generic Drug User Fee Deal Creates Domestic-Focused Incentives, Could Lower Application Fees: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-user-fee-deals-creates-domestic-focused-incentives-could-lower-application-fees-UOG7BGF2YNA3NMWHLFMM2C2BFU/ Generic Drug User Fee Agreement Streamlines Meetings, Creates ‘Complex Issue’ Goal Extension: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/generic-drug-user-fee-agreement-streamlines-meetings-creates-complex-issue-goal-extension-TZFGYWV2VNCF3M7GJWPOJZ66SI/

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

Citeline Podcasts

Hello and welcome to another edition of Drug Fix, the Pink Sheets Pharma Regulatory Podcast. I'm Derek Ingerie, an Executive Editor at the Pink Sheet. I'm joined by Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs. Today is August 14th, 2026. This is supposed to be a slow period for the FDA since lots of people take summer vacations and are preparing for school to begin again. But we were all just joking recently that this month has really not been slow at all, including this week with the user fee agreements being released.

Not that I'm complaining. Just a reminder before we get going to hit the like and subscribe buttons on Apple Podcasts and Spotify and make sure you're getting every episode. If you like what you heard, give us a five star review. That really helps us out. Today we're going to talk about the prescription drug and generic drug user fee reauthorization agreements that the FDA released this week. These agreements help govern the spending of more than a billion dollars in revenue that the FDA will receive annually from application and other fees.

Every five years, the agreements must be renewed and usually are updated. First is the PDUFA 8 agreement. By the way, I'm proud to say this is my fourth PDUFA renewal that I've covered. Aside from setting the usual fees for applications, the agreement also will expand some formal meeting programs, including the model informed drug development and rare disease endpoint advancement programs. Those programs eventually will transition to ongoing availability rather than a limited number of participants.

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

Read the full transcript

The candid version is on a podcast,
not the earnings call.

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

Read the full transcript

The candid version is on a podcast, not the earnings call.

The candid version is on a podcast,
not the earnings call.