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5 Nov 2023, 1:02 pm by Stuart Kaplow
” Accordingly, the petitions seeking to block the rules were rejected. [read post]
3 Nov 2023, 3:01 pm by Daniel J. Gilman
I don’t mean to sound like a broken record, but why is the Federal Communications Commission (FCC) playing a broken record? [read post]
1 Nov 2023, 9:41 pm by Kurt R. Karst
We recount a few milestones along the road here: 1997 ASR Rule restricts sale, distribution of analyte specific reagents; FDA asserts authority over LDTs but articulates enforcement discretion policy 1998 FDA denies Citizen Petition submitted in 1992 on behalf of several clinical laboratories challenging agency authority over “home brew” tests 2006 FDA issues draft guidance (indefinitely delayed) outlining a different enforcement approach for in vitro diagnostic multivariate index assays… [read post]
1 Nov 2023, 7:12 am by Chase Strangio
We have witnessed this court disregard and infringe people’s bodily autonomy repeatedly, most recently with its devastating decision in Dobbs, which overturned Roe v. [read post]
1 Nov 2023, 6:14 am by Ellena Erskine
ShareThe justices will hear oral argument this morning in Vidal v. [read post]