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Articles 1 - 4 of 4
Full-Text Articles in Consumer Protection Law
Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck
Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck
Seattle University Law Review
This Note seeks to address the issues concerning the FDA’s approval of genetically modified salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. Part I provides a brief history of AquAdvantage salmon’s introduction to U.S. markets and the legal actions taken in response to the FDA ruling. Part II discusses the statutes and regulations fundamentally relevant to GE products, as well as a critique of the way each regulation was used to approve AquAdvantage. Part III offers a comparison to the European …
When The Feds Have Taken The Field: Federal Field Preemption Of Claims Against Manufacturers Whose Medical Devices Have Received Premarket Approval By The Fda, Charles Warren
Oklahoma Journal of Law and Technology
No abstract provided.
Using Data Exclusivity Grants To Incentivize Cumulative Innovation Of Biologics' Manufacturing Processes, Eric Lawrence Levi
Using Data Exclusivity Grants To Incentivize Cumulative Innovation Of Biologics' Manufacturing Processes, Eric Lawrence Levi
American University Law Review
No abstract provided.
Substantiating Big Data In Health Care, Nathan Cortez
Substantiating Big Data In Health Care, Nathan Cortez
Faculty Journal Articles and Book Chapters
Predictive analytics and "big data" are emerging as important new tools for diagnosing and treating patients. But as data collection becomes more pervasive, and as machine learning and analytical methods become more sophisticated, the companies that traffic in health-related big data will face competitive pressures to make more aggressive claims regarding what their programs can predict. Already, patients, practitioners, and payors are inundated with claims that software programs, "apps," and other forms of predictive analytics can help solve some of the health care system's most pressing problems. This article considers the evidence and substantiation that we should require of these …