Life Science Compliance Update

August

2017

August 2017: Life Science Compliance Update

Written by , Posted in August 2017 LSC Update, This Month in Compliance

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August 2017 LSCU Cover

Issue Summary

Welcome to the Dog Days of Summer! This month we focus once more on off-label promotion, with a special three-part series. We also take a look at recent developments involving the Escobar case and the latest from the U.S. Supreme Court on products liability/mass tort jurisdiction. Finally, we have an article from Matt Kelly on the Fine Art of Policy Management.


LSCU Special Feature

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A Murky Future for Off-label Promotion

Within the world of life science product regulation, the area of off-label promotion is perhaps the most complicated, emotional and uncertain of all. It is an ever-changing landscape of regulations, court decisions and now politics. It is a landscape that the LSCU has covered in many issues, and once more it is making headlines. This three-part series will explore the impact that the new FDA Commissioner will have on the debate, how Congressional efforts could make things even more complicated for life science compliance professionals, and the latest efforts by Arizona to allow off-label promotion. – Dr. Seth Whitelaw, Editor

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PART 1: New Leadership at the FDA Brings Change
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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PART 2: Off-Label Bills Garner Minimal Traction in Congress
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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PART 3: States vs. FDA – Arizona to Allow Pharma Companies to Legally Communicate Off-Label Treatment Options
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Other Issue Articles

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A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Independent Review Organizations (“IRO”) and Conflicts of Interest – Much Ado About Nothing or a Serious Problem
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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The Fine Art of Policy Management
Matt Kelly, Editor & CEO at Radical Compliance
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This Isn’t Walmart: The Supreme Court Narrows Forum-Shopping Options
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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