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False Claims Act
Amarin and FDA Off Label Free Speech Settlement
The United States Food and Drug Administration (FDA) and Amarin announced that they have reached a proposed settlement…
Tenet Healthcare Settlement Offer
Tenet has been locked in a legal battle against allegations that four of its hospitals violated the Anti-Kickback Statute and the…
CMS Issues Final 60 Day Payment Rule
The Sixty Day Rule
The Centers for Medicare and Medicaid Services (CMS) has finally issued its final rule related to…
DOJ Becoming Comfortable With Permitting Truthful, Non-misleading Promotion
As we know all too well, the U.S. Food and Drug Administration (FDA) has long taken the position that a medical device…
Off-label Marketing is “Dead,” Diversion Cases on the Rise
"Off-label marketing is dead so-to-speak. There's been a death knell of that."
That news was delivered by Charlene…
Pacira Update: A Settlement in the Works?
As we have previously written, the FDA has recently removed the Pacira warning letter from their website, which set off a…
DOJ: Nearly 500 Hospitals Pay United States Over $250 Million to Resolve…
The Department of Justice announced on Friday, October 30, that they have reached 70 individual settlements involving…
Novartis Announces $390 Million False Claims Act Settlement on Rebates to…
Novartis AG, the world's largest seller of prescription drugs, has announced a $390 million tentative agreement to…