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- Hacker News
- At least clowns can be fun to watchby ubiquitysc
- It’s much less fun if you have a loved one, say an aggressive autoimmune disease. Do not recommend.by vibrio
- From another country, it is mildly amusing in one sense of schadenfreude.
It is also incredibly saddening to see great institutions of expertise be treated as playthings by the ignorant.
by _carbyau_ - “He had the temerity to reject a drug that had lousy data…”
Was that data really “lousy”? (Referencing the REPL data?) Was it a trial design issue? (which he has very strong and unconventional opinions on) Is it the role of his position to overrule his specialist review teams ? (in the absence of any clear safety risks or malfeasance)
by vibrio - My ex works in QA for a biotech company and FDA audits are a regular thing and are taken very seriously.
There's plenty to criticize of the org (as with almost all others) but the rank and file are doing good work to help try to keep us safe.
by pstuart - This. They don’t get paid much, or much glory if any, but overall they are smart and hard working and are eager to have rational and data driven discussions about the programs they oversee. Current status is heartbreaking.by vibrio
- And they are slowly being attrited by layoffs, being led by corrupt shitbirds, and the Russell Vought ethos of making career public servants miserable.by cosmicgadget
- I work in biotech and the FDA is openly reviewing our submissions with LLMs now. The shark has been jumped.
https://www.fda.gov/news-events/press-announcements/fda-anno...
by wswope - >In early August, soon after joining the FDA, Tidmarsh announced actions that would effectively remove from the market a drug ingredient made by a company associated with Tang. Tidmarsh’s lawyer then sent a letter to Tang proposing that he extend a “service agreement” for “another 10 years,” which would see Tang making payments to a Tidmarsh-associated entity until 2044. The email was seen as attempted extortion, with such payments being in exchange for Tidmarsh rolling back the FDA’s regulatory change.
Straight up extortion.
by duxup - This makes me wonder how much of the Tariffs are extortion of other countries.
How randomly they seem to be applied to makes me wonder if theres back room deals going on.
by teddy-smith - it's crazy how much of the current regime's position is "crime is legal if it's my guys doing it."by Kapura