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)
It is also incredibly saddening to see great institutions of expertise be treated as playthings by the ignorant.
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.
https://www.fda.gov/news-events/press-announcements/fda-anno...
One (of many) issue is that this has no bearing on other regulatory regimes. So, sure, the FDA approves of the drug/device/thingy because the AI got lost and no one is checking what it's saying. But Canada's CFIA doesn't because they are still using real people or centaurs ( people + AI, but I'm not 100% sure so don't quote me on that ).
That makes it so that you can only sell the drug/device/thingy in the US and some other countries that blindly follow US FDA (mostly poorer nations with very small markets and a lack of legal recourse, they'll just turn to the EFSA/EMA).
Which fine, but that is not the bet that these large companies made about a decade ago when it came to whether or not this drug/device/thingy would be worth it to pursue. These big drugs need to pay off all the failed research with international sales. Same is somewhat true with devices (mostly internal these days). These big drug makers want stability. Profits are fine, but revenue is just as important as these pipelines are sooooo long and soooo fraught. The human body is just too variable.
The tariffs and all the monkey business with this admin is very much not good for the US when it comes to these large drug/device/thingy makers. Chaos is not good for business. They have all learned that Donny and his ilk (per the article here) do not keep their words when it comes to corruption. They do not stay bought, they are not stable.
We're already shedding jobs here in favor of moving to the EU. Yes, not India or China, but the Baltics mostly (inside Schengen zone). We lost 10 people with jobs opening up there (same day) just this last week. The EU is stable in the eyes of my very own bosses.
Interesting.
So you're seeing "scientific development" pipelines (research/development/trials) moving wholesale to EU?
duxup•3mo ago
Straight up extortion.
Kapura•3mo ago
watwut•3mo ago
Edit: I do not mean it cynically or as a joke. I think that is exactly what conservative position was for years. The only difference now is that it is not possible to euphemism away or plausible deniality away out of it.
smithoc•3mo ago
The MAGA movement has completely purged all the conservatives from the Republican party.
They've increased the deficit by a trillion dollars, built an army of ICE agents and deployed them to terrorize people in cities around the country, added billions of dollars in import taxes, taken state ownership stakes in multiple companies.
They're closer to Stalin or Mao than to any conservative ideology of a small government that stays out of people's business.
tastyface•3mo ago
teddy-smith•3mo ago
How randomly they seem to be applied to makes me wonder if theres back room deals going on.
yongjik•3mo ago
tastyface•3mo ago
yongjik•3mo ago