Life Science Compliance Update

April

2016

A Basic Geometry Lesson – FDA’s Off-label Losses

Written by , Posted in Pricing

Kaitlin P. Fallon, Esq., Staff Writer for Life Science Compliance Update

The new decision in United States v. Vascular Solutions, Inc., provides the third point in a curve of the FDA’s regulation of off-label promotion. This article provides a detailed explanation of the case, including the relevant jury instruction, an overview of the 2014 FDA Guidance document on scientific and medical publications, and possibilities for next steps for compliance officers.


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