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Life Science Compliance Update
Pharmaceutical and Device Manufacturers: Buyer Seller Beware
Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as…
LSCU SPECIAL FEATURE: Into the Nexus – Anti-Kickback Statute…
Part 2: The Tension Increases - Online Auctions Violate the AKS
We have noted in previous articles that there is an increasing…
LSCU SPECIAL FEATURE: Into the Nexus – Anti-Kickback Statute…
Part 1: An Uncertain Future in a Dynamic Landscape
Fans of Star Trek will remember the scene from the 1994 movie “Generations”…
The California Hurdle – SB 790 and Pharma
Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems…
Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG…
Measuring the effectiveness of compliance programs is no easy task since governing agencies have not published a template that…
This is Not Your Parent’s Compliance Program – The New Era of Compliance…
At the 14th Annual CBI Pharmaceutical Compliance Congress held in April 2017, almost half the attendees were from small to…
The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?
The 21st Century Cures Act (“Act”), which provides substantial funding for medical research, seeks to alleviate the regulatory…
An FCA Journey – Allergan to Pay $53M to DOJ
Allergan has been hit with hefty fines over the past several months. This article outlines Allergan's alleged wrongdoing, and the…
Genentech & Escobar: Using Materiality to Escape False Claims…
In constructively bringing an end to a False Claims Act (“FCA”) whistleblower suit alleging Genentech, Inc. (“Genentech”) of…
Chicago’s Attempt to Regulate Drug Reps – A Real Public Health…
Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has…