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.
I don't know. If this speeds up their work and helps them do more with the same staff I can see this as being a good thing. a.i. is really good at combing through data to answer questions.
It will not.
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.
And they are slowly being attrited by layoffs, being led by corrupt shitbirds, and the Russell Vought ethos of making career public servants miserable.
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...