Largest Medicare/Medicaid Fraud Takedown in History
The Department of Justice (DOJ) recently announced that it is charging hundreds of individuals across the country with committing…
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What You Don’t Know About AMP Can Hurt You: PART 1 – In the Beginning
Since the US Government uses AMP to set Medicaid rebates, as well as the Medicaid Federal Upper Limit (FUL), it is vital the…
PhRMA and BIO Release Drug Maker Communication Guidelines
On Wednesday, July 27, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation…
Ubl Gets Personal, Lays Out Vision for Future of PhRMA
PhRMA President and CEO Steve Ubl recently joined the Medium blogging website and penned his first post, "Health Care Veteran…
The Olympus Settlement – What It Can Tell Us About the Compliance Officer
When dissecting recent settlements, we normally look at the underlying events and process failures. The recent Olympus settlement,…
FDA Guidance Data Integrity and Compliance With CGMP
In recent years, FDA has increasingly observed current good manufacturing practice (cGMP) violations involving data integrity…
Give Thanks for Your Compliance Officers – Reviewing Public Citizen’s Study…
Thanks to an increase in experienced compliance officers, settlements and court judgments between pharmaceutical manufacturers and…
Acclarent Executive Convicted of Misdemeanors and Acquitted of Felonies
The former Chief Executive Officer and Vice President of Sales of Acclarent, Inc., a medical device company and division of…
It’s A Brave New World or Is It? – CIAs and Their Ability to Create…
Corporate Integrity Agreement (CIAs) are a tool commonly employed by the HHS OIG to resolve healthcare fraud issues. This article…
FDA: Draft Guidance – Procedures for Evaluating Appearance Issues and…
FDA released draft guidance to deal with what it describes as "appearance issues" that make advisory committee members…