The cornerstone of many FDA enforcement actions against pharmaceuticals manufacturers in recent years has been the charge that they have "misbranded" their pharmaceutical products by promoting them for uses not approved by the FDA. Now, the Second Circuit has thrown the concept of criminal liability for misbranding by means of off-label-use promotion into turmoil.
A discussion of several key cases.
The OCR is putting new emphasis on enforcing patient privacy rights since the passage of HITECH in 2009. A look at four settlement agreements.
The California Supreme Court has taken a keen interest in the peer-review process in recent years. Here's why.
This article examines the relationship between Pliva and the Patient Safety and Generic Labeling Improvement Act, and discusses the potential ramifications for generic drug manufacturers should the Act be signed into law.
