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I assume it doesn't because U.S.-government-level "inquiry and scrutiny" takes at least an order of magnitude longer than 72 hours. If they're getting this done
by smeej 4y ago
I assume it doesn't because U.S.-government-level "inquiry and scrutiny" takes at least an order of magnitude longer than 72 hours. If they're getting this done in time for it to be useful, it's just being rubber-stamped.
Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? If not, drop the red herring and try to have a halfway serious discussion.
- 411111111111111 4y agoI mean the argument was that that "they have to keep filling out these forms, causing lots of overtime", that was the argument I pointed out to be unreasonably dumb considering it's less then 5 times per year. So... The one that's doing that is pretty much you. None of us can argue about wherever the drug should be approved by now, as we don't know why it isn't yet. You'd have to first get a statement from the agency before that discussion can take place
- s1artibartfast 4y agoI do think there is patient tracking after the fact, and that the reason for exemption is examined. >Do you sincerely think the EU would keep a drug available for common use if everyone who took it died? No, but this is the type of data the FDA will collect and verify. It is not an approved product so they don't have this data tracking on it like they would for a normal product. I guess I dont think your central point is credible. You dont think that a form can be examined to see if it has a doctors approval and valid need within 72 hours? Here is the process if you want to educate yourself: https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#PhysicianEmergency-sbs https://www.fda.gov/news-events/expanded-access/expanded-acc...