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Sue Sutter

Aug 14, 2026

2:44
Obviously, with the FDA's issues with recruitment and retention, committing to adding even more people is a significant thing, right?
2:52
Oh, yeah.
2:53
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.
3:11
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.
3:30
They're not just going to get all the money.
3:32
They want immediately to do whatever they want in terms of hiring.
3:35
They have to show that they are hiring in order to get some of these fees.

12 MINS LATER

15:36
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?
2:44
Obviously, with the FDA's issues with recruitment and retention, committing to adding even more people is a significant thing, right?
2:52
Oh, yeah.
2:53
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.
3:11
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.
3:30
They're not just going to get all the money.
3:32
They want immediately to do whatever they want in terms of hiring.
3:35
They have to show that they are hiring in order to get some of these fees.

12 MINS LATER

15:36
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?

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