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Articles 1 - 6 of 6
Full-Text Articles in Law
A Proposal For Fda Label Regulations And Uniform Certifications For Organic Non-Food And "Natural" Products, Allyson Bartolomeo
A Proposal For Fda Label Regulations And Uniform Certifications For Organic Non-Food And "Natural" Products, Allyson Bartolomeo
Barry Law Review
No abstract provided.
The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid
The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid
University of Miami Business Law Review
In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common …
The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng
Seattle University Law Review
Part I of this Note provides background information about the major controversies related to GM foods, including the debate about whether such foods should be labeled, and the history of GMO labeling laws in the United States. Part II compares S. 764 with H.R. 1599 and explains why a national mandatory labeling approach is superior to the voluntary labeling approach advocated by the House. Part III discusses the potential drawbacks and effect of S. 764 and finally concludes that the rulemaking process that will follow may create controversies and litigation.
The Prescription For Rising Drug Prices: Competition Or Price Controls?, Joanna Shepherd
The Prescription For Rising Drug Prices: Competition Or Price Controls?, Joanna Shepherd
Health Matrix: The Journal of Law-Medicine
The article focuses on the implementing of reforms aimed at promoting competition or prohibiting anticompetitive practices in rising drug prices in the U.S.
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise
Faculty Publications & Other Works
No abstract provided.
The Statutory Case Against Off-Label Promotion, Nathan Cortez
The Statutory Case Against Off-Label Promotion, Nathan Cortez
Faculty Journal Articles and Book Chapters
The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …