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Food and Drug Law Commons

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Full-Text Articles in Food and Drug Law

Weird Science: Frankenstein Foods And States As Laboratories Of Democracy, Jennifer Mcgee Jul 2017

Weird Science: Frankenstein Foods And States As Laboratories Of Democracy, Jennifer Mcgee

Journal of Law and Health

The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont’s Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National …


Crispr: Redefining Gmos—One Edit At A Time, Eric E. Williams Apr 2017

Crispr: Redefining Gmos—One Edit At A Time, Eric E. Williams

University of Arkansas at Little Rock Law Review

No abstract provided.


23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely Jan 2014

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.


The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud Jan 2013

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …


Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone May 2003

Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone

Michigan Law Review

With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …