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Full-Text Articles in Law
Neglecting Nationalism, Gil Seinfeld
Neglecting Nationalism, Gil Seinfeld
Articles
Federalism is a system of government that calls for the division of power between a central authority and member states. It is designed to secure benefits that flow from centralization and from devolution, as well as benefits that accrue from a simultaneous commitment to both. A student of modern American federalism, however, might have a very different impression, for significant swaths of the case law and scholarly commentary on the subject neglect the centralizing, nationalist side of the federal balance. This claim may come as a surprise, since it is obviously the case that our national government has become immensely …
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
University of Michigan Journal of Law Reform
The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …