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Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Miles , 360 F.3d 3d 472 (5thCir.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law

Of note, the 2004 accelerated approval of natalizumab (Tysabri) for relapsing-remitting multiple sclerosis was based on the Kurtzke Expanded Disability Status Scale (EDSS) score at one-year; two-year EDSS data were used to verify and describe the clinical benefit for conversion to traditional approval.

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