Center for Tobacco Products

All right, so as I said at the top, we're gonna start with the FDA this week.

In addition to some of the news I teased in the intro, last week, shortly after recording this podcast in fact, we learned from the FDA that it was making the acting directors of CBER and CDER, those are its two main drug and biologics review units, along with the acting director of the Center for Tobacco Products, made all three of those men permanent in their positions.

I can't really speak directly to Bhet Kapila's work at the tobacco unit, but I have heard Kareem McAleer and Michael Davis speak at BIO.

At the international convention in June they spoke, and I, I honestly was impressed.

So, um, Brian, maybe we can, we can go back to you and just, um, uh, you know, comment on, uh, any of the other-- You know, I think those are the two, uh, you know, main appointments that, that really have read through to biotech.

There were also, uh, you know, there were also appointments in, uh, you know, for Center of Tobacco Products and, uh, you know, a new, um, a new appointment as Deputy Commissioner for, uh, Technology and Artificial Intelligence, uh, to Jared Seehofer.

Um, but maybe Brian, you could, you could share any, uh, you know, any views on, on these selections and what it means for biotech.

Yeah, yeah, happy to, and, and, you know, would love to have input from the rest of the, the group here and, and, you know, nothing against Jared and, and, and Brett, but, uh, uh, probably doesn't matter to, to, in the context of, uh, analyzing biopharma.

Makary resigned in May.

The FDA also appointed a longtime employee to direct the Center for Tobacco Products.

Finally, the agency created a new position, Deputy Commissioner for Technology and Artificial Intelligence.

Jared Seehafer, who spent most of his career in the private sector, will lead technology, software, and AI.