Orphan drugs

01
Oct

Slicing the Bologna Too Thin Leads to Appeals Court’s Overturning District Court’s Ruling – Harkens Back to Skinny Label in Recent “Inducement to Infringe” Decisions – I’m Confused

Everyone knows that I am not a lawyer; I’m just a regulatory geek.  But in the case of Catalyst Pharmaceuticals v. FDA and Jacobus in an orphan drug dispute, where the case rested on whether the phrase “same disease or condition” is ambiguous, there are few things that confuse me. The central issue is the […]

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