The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.
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?
- Who says crime doesn’t pay
- Whistleblowing UK-style
- Getting it backwards – guilty until proven innocent
- Even the government cheats