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Preemption

Mensing and Its Impact


Question:What is Mensing and what is its impact for generic-drug manufacturers? Answer: In Pliva, Inc. v. Mensing1, the U.S. Supreme Court provided its latest pronouncement on...

The Basics of Contractual Risk Transfer


In an age of outsourcing, before a finished medical device or pharmaceutical product reaches its end user, it will be "touched," literally and figuratively, by multiple vendors, such as...

Risk Shifting Through Contracts: Meaning & Examples


Abstract: In an increasingly global economy, medical device manufacturers are finding that they must rely more and more on supply chains in order to control costs and successfully compete...

Preemption Defense for Generic Pharmaceutical Companies


Generic pharmaceutical manufacturers recently received an historic victory from the highest court in the land. In Pliva, Inc. v. Mensing, the United States Supreme Court held that federal...