FDA Plans To Continue Diagnostics Reform Fight
In a recent webinar about the agency’s current regulatory and legislative priorities, FDA Deputy Commissioner Andi Fristedt called the way diagnostics are now regulated “untenable.”
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A measure that would have moved diagnostics regulation under the US Food and Drug Administration has been culled from the year-end omnibus spending package.
This feature compiles news briefs on a range of US regulatory and legal happenings. This week: Medtronic seeks HeartWare batteries; companies sign health equity pledge; insulin dosing app cleared; recall on field decontamination kits; and the renewal of an FDA panel.
A recent webinar ranking last year’s best and worst legal verdicts said that product liability cases involving pelvic mesh and artificial lenses were the very worst.