Prescription Drug User Fee Act

The FDA has been busy this week.

They held public meetings on psychedelic therapies, as well as PDUFA VIII.

The agency has also formally announced the launch of the application process for the IND pilot program that it's running as part of the HHS-wide initiative known as Operation Trial Blazer, aimed at reshoring early clinical trials.

So we'll discuss all of that with you.

Like I said, it was a busy week for the agency.

They are having another public meeting today, Wednesday, as you're listening to this.

This one will hear what s- industry stakeholders want to see included in the latest iteration of PDUFA.

That's the Prescription Drug User Fee Act.

So they need, you know, stabilized CBER leadership and expectations, and then they can hire.

I think this PDUFA letter actually was a good letter.

made a lot of commitments that are not like seismic, but are important progress.

And so I want to see Congress codify that and attach some policy riders to it for improved clinical trials.

And most of all, I want to see what comes out of this new PDUFA to be more early stage engagement that then creates consistent touch points throughout the entire process.

What I hear from industry is we want really high standards.

What we don't want is nebulous or changing answers early on.

What I have heard is that really starting with COVID, I think that engagement started to get a little looser and we want to tighten it up again.