Holly Fernandez Lynch
@hollylynchez.bsky.social
Academic lawyer/bioethicist studying pharmaceutical policy, access to investigational medicines, IRB quality (www.aereo.org), and clinical research ethics and regulation, with a splash of psychedelics.
Somehow I disconnected the follow up from the main post:
bsky.app/profile/holl...
bsky.app/profile/holl...
And 2. This policymaking via journal article has to stop. This should be guidance w/ opportunity for public comment not just peer review. Guidance docs also have the benefit of being easily searchable on FDA's website.
By all means, write an article after a guidance, but stop flipping the order.
By all means, write an article after a guidance, but stop flipping the order.
December 8, 2025 at 7:01 PM
Somehow I disconnected the follow up from the main post:
bsky.app/profile/holl...
bsky.app/profile/holl...
Because guidance docs don't look as good on a CV?
a black and white photo of a woman wearing a turtleneck sweater and a dress .
ALT: a black and white photo of a woman wearing a turtleneck sweater and a dress .
media.tenor.com
December 8, 2025 at 6:33 PM
Because guidance docs don't look as good on a CV?
Reposted by Holly Fernandez Lynch
90% of senior FDA staff are gone. bsky.app/profile/pear...
Here's a link to the full BioSpace post: www.biospace.com/fda/pazdurs-...
Pazdur’s Sudden Exit Leaves Just Three Veterans in FDA’s Senior Ranks
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
www.biospace.com
December 4, 2025 at 7:14 PM
90% of senior FDA staff are gone. bsky.app/profile/pear...
I'd add hubris to the incompetence bucket.
December 4, 2025 at 1:38 PM
I'd add hubris to the incompetence bucket.
What do you think are the reasons, Hank?
December 4, 2025 at 3:26 AM
What do you think are the reasons, Hank?