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Life Science Compliance Update
Exploring Strage New Worlds – FDA’s 2016 Program Alignment and…
This article provides an overview of the FDA's initiative to realign programs from location-centered structures and…
Do Gold-Standard CIAs Get Blue Ribbon Approval?
Corporate Integrity Agreements are thought to set the standard for compliance programs, but when viewed against the norms…
Tick-tock – The Role of Compliance in M&A
activities In this article, we review advice from industry thought leaders on (1) how to ensure compliance officers are a part of…
The FDA Shield – The Medtronic Infuse Case and the Latest Tango of…
The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences…
That’s The Fact Jack – MedJack and Device Cybersecurity
The recent revelations by Cyber Security experts regarding the significant vulnerabilities of medical devices to so-called…
A Basic Geometry Lesson – FDA’s Off-label Losses
Lon - FDA's Off-label
The new decision in United States v. Vascular Solutions, Inc., provides the third point in a curve of…