Features
Drug Marketing to Doctors: Changes May Be On the Way
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.
HITECH and HIPAA Enforcement Activities
The OCR is putting new emphasis on enforcing patient privacy rights since the passage of HITECH in 2009. A look at four settlement agreements.
Features
Filing Whistleblower Actions to Avoid Peer Review
The California Supreme Court has taken a keen interest in the peer-review process in recent years. Here's why.
Undoing Pliva Inc. v. Mensing
This article examines the relationship between <i>Pliva</i> 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.
Need Help?
- Prefer an IP authenticated environment? Request a transition or call 800-756-8993.
- Need other assistance? email Customer Service or call 1-877-256-2472.
MOST POPULAR STORIES
- Major Differences In UK, U.S. Copyright LawsThis article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.Read More ›
- The Article 8 Opt InThe Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.Read More ›
- Removing Restrictive Covenants In New YorkIn Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?Read More ›
- Warehouse Liability: Know Before You Stow!As consumers continue to shift purchasing and consumption habits in the aftermath of the pandemic, manufacturers are increasingly reliant on third-party logistics and warehousing to ensure their products timely reach the market.Read More ›