Post #2422914
2026-03-17 23:10 UTC
@marz@caw.corbode.com @akesi_Anima@mastodon.art @twistylittlepassages@weirder.earth
The registry:
> Mandate Enhanced Adverse Event Reporting: In addition to a robust REMS, establish a formal system for rigorous post-market surveillance of this off-label use [...] and require manufacturers to establish a patient registry as part of a REMS to capture real-world safety data
... safety data they can at min cherry pick, at max much worse
Desp the FDA just removing a similar label, per the other link
Replies (1)
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@marz@caw.corbode.com 2026-03-17 23:23
@jhwgh1968@chaos.social @twistylittlepassages@weirder.earth Ah gotcha. That would still be held by manufacturers who would have to comply with PHI laws and not hand it directly to the federal government I would think but also I don't trust this administration at all so I get the concern.