I (sadly) need to update that piece to add like another 3 things that have popped up in the last week alone. It's going to be a sobering few months for FDA staff.

This is a dream role for someone who loves writing and is an encyclopedia of knowledge about food and chemical regulatory policy (and is gifted at explaining how things work to an audience of both experts and laypersons).

The role is based in Rosslyn, VA (3 days a week).

The form used to look like this:

Now it just asks if the patient was assigned Male or Female at birth.

I think historically CDRH had regulated them because the mechanism of action of the leeches/maggots was mechanical (extracting blood, consuming dead tissue), rather than biological.

They are still submitted as device applications, too.

www.nbcnews.com/health/healt...

I write a free daily newsletter, FDA Today, focused on life sciences regulation from a US perspective.

My group also has a European-focused newsletter, EMA Today, covering the same scope.

www.agencyiq.com/subscribe-fd...

www.agencyiq.com/subscribe-em...

I suspect this is going to be an increasing concern as a lot more people look to replace plastic (vinyl) cooking utensils with metal ones in an attempt to limit their exposure to PFAS or other contaminants.

Lots of crap in the metal supply chain, too.

Most of their work is focused on improving patient access to cancer drugs, helping patients meet with regulators, holding meetings to address public health issues (tons of work on opioid policy issues), and writing reports.

A bizarre thing to focus on, since they get like $1.6M in FDA funding.

Thank you for the kind words!

Thanks for sharing, Holly!

In particular, I was really frustrated to see analysis that seemed to only look at FDA's role as approving vaccines.

No. FDA also informs drug labels, issues warnings, sets indications for use, establishes risk control measures, reviews and clears clinical trial requests, issues guidance, and more

For example, while this KFF piece is a great primer (seriously, go read it), it misses a *huge* number of the important levers available to RFK to really interfere with vaccines from an FDA perspective.

www.kff.org/policy-watch...