Life Science Compliance Update



November 2015: Life Science Compliance Update

Written by , Posted in New This Month, November 2015 LSC, This Month in Compliance

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October 2015 LSCU Cover

Issue Summary

The November issue features an article on the latest qui tam case involving Takeda, which breaks new ground as the plaintiff is a customer as well as an investigative author.  Nicodermo (Nico) Fiorentino, Senior Advisor, Research & Compliance, for G&M Health LLC., contributed a great roundup on the EU Data Privacy and the impact of the invalidation of the US-EU Safe Harbor Framework.  We also take a look at the state of medical device preemption after the case of Caplinger v. Medtronic, Inc., and delve into the muddy waters of FDA’s social media guidance.

Finally, in a new section called the Editor’s Corner, our new editor, Seth Whitelaw reflects on what it takes to find and engage a good life sciences compliance officer.

Table of Contents


Letter from the Editor


Editor’s Corner: Reflections On Finding and Engaging a Good Compliance Officer


Litigation: Takeda Qui Tam Breaks New Ground


Data Privacy: Sailing with No Safe Harbor In Sight:  What is the Next Destination for US-EU Data Privacy?


Medical Devices: Federal Preemption and Medtronic: The Seemingly Endless Merry-Go Round


Social Media: A Journey Without End? FDA and Social Media Guidance


Transparency: Academics On The Board – A True Problem Or A Hammer Looking For A Nail?


Briefly Noteworthy

  • Who says crime doesn’t pay
  • Whistleblowing UK-style
  • Getting it backwards – guilty until proven innocent
  • Even the government cheats
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