Life Science Compliance Update

March

2017

March 2017: Life Science Compliance Update

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

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March 2017 LSCU Cover

Issue Summary

It’s March madness for Life Science Compliance. Medical devices are our focus this month. First, we highlight at all the new FDA device guidances issued when Obama departed the White House. We also look at how the FCA can impact devices with the Shire settlement. Also on the enforcement front, we explore whether DPA’s work as intended, as well as dive into the FY 2016 FCA recovery numbers. We finish up with two articles from Mitchell Hamline law students, Matthew Gunzehauser and Corey Hoze and one from Darren Jones of Polaris Management Partners on the future of life science compliance.


Feature Article

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Privacy Regulation: The Final Frontier of Life Science Compliance
Matthew Gunzenhauser
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Issue Articles

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Accountability: The shifting landscape of compliance responsibilities
Darren Jones, Managing Partner, Polaris Management Partners
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Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?
Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)
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A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Medical Devices & False Claims – Shire’s Settlement Is One for the History Books
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Do DPA’s Work? – The BioMet Case Study
Robert N. Wilkey, Esq., LSCU Staff Writer
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DOJ Has Third Highest Annual Recovery in FCA History
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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