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Full-Text Articles in Law
Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray
Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray
Michigan Telecommunications & Technology Law Review
If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …
A New History And Discussion Of 180-Day Exclusivity, Erika Lietzan, David E. Korn, Shaw W. Scott
A New History And Discussion Of 180-Day Exclusivity, Erika Lietzan, David E. Korn, Shaw W. Scott
Faculty Publications
This is the third in a series of articles on 180-day exclusivity. The first article traced the history of 180-day exclusivity from 1984 through its amendment in 2003 and court cases in 2004. A second article, published by two of the authors in 2007, updated the earlier piece through the end of 2006 but was arranged by issue rather than in a chronology. This article, which includes a third author, provides a comprehensive resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) (but less detail in some places where the 2007 article may be referenced) and focuses more …