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Sue Sutter
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Aug 14, 2026
Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change
2:44
2:53
3:11
15:36

Derrick GingeryHOST
Obviously, with the FDA's issues with recruitment and retention, committing to adding even more people is a significant thing, right?

Sue SutterGUEST
That's a constant feature of the PDUFA negotiations, cycle in and cycle out, right? and takes on a real urgency now as they try to restaff following the various personnel moves at the beginning of the second Trump administration.

Sue SutterGUEST
So it's interesting that they're not getting a blank check from industry as much as industry has been supportive of the efforts to ensure continuity and experience and strength at the FDA.
12 MINS LATER

Derrick GingeryHOST
First of all, Matt, I wanted to ask you, you know, which naming convention do you prefer for the meetings? Do you like 306090 or ABC better?
Drug Fix: Understanding The PDUFA VIII Revenue Cut And GDUFA IV Name Change
2:44
2:53
3:11
15:36

Derrick GingeryHOST
Obviously, with the FDA's issues with recruitment and retention, committing to adding even more people is a significant thing, right?

Sue SutterGUEST
That's a constant feature of the PDUFA negotiations, cycle in and cycle out, right? and takes on a real urgency now as they try to restaff following the various personnel moves at the beginning of the second Trump administration.

Sue SutterGUEST
So it's interesting that they're not getting a blank check from industry as much as industry has been supportive of the efforts to ensure continuity and experience and strength at the FDA.
12 MINS LATER

Derrick GingeryHOST
First of all, Matt, I wanted to ask you, you know, which naming convention do you prefer for the meetings? Do you like 306090 or ABC better?