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Articles 631 - 660 of 992
Full-Text Articles in Food and Drug Law
The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith
The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith
Sustainable Development Law & Policy
Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.
Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely
Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely
Sustainable Development Law & Policy
No abstract provided.
Editor's Note, Luke Trompeter, Ingrid Lesemann
Editor's Note, Luke Trompeter, Ingrid Lesemann
Sustainable Development Law & Policy
No abstract provided.
Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa
Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa
Faculty Works
This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article …
Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed
Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed
Georgia State University Law Review
The Act amends Georgia’s controlled-substances statutes to expand medical provider requirements to record prescription drug information in an electronic prescription drug monitoring program database (PDMP). Medical providers are now required to use the PDMP to enter information about their prescription of certain types and quantities of opioids. The purpose of the act is to fight Schedule II opioid abuse throughout the state of Georgia. A medical provider’s failure to report required information is reported to his or her respective state regulatory board for possible reprimand. In addition to mandatory reporting, the Act includes various other provisions related to regulating opioid …
Sb 104 - Carjacking, Fentanyl And "Upskirting", Katherine H. Krouse, Lauren R. Light
Sb 104 - Carjacking, Fentanyl And "Upskirting", Katherine H. Krouse, Lauren R. Light
Georgia State University Law Review
The Act includes various amendments to Georgia’s criminal code. Three changes are most notable. First, the Act designates the offense of hijacking a motor vehicle as hijacking a motor vehicle in the first degree and creates the offense of hijacking a motor vehicle in the second degree. Second, the Act criminalizes the use of a device to film underneath or through an individual’s clothing. Lastly, the Act adds the drug Fentanyl and its various analogs to the list of controlled substances.
Localism, Labels, And Animal Welfare, Samuel R. Wiseman
Localism, Labels, And Animal Welfare, Samuel R. Wiseman
Northwestern Journal of Law & Social Policy
The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanely-raised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …
Privacy Of Information And Dna Testing Kits, Shanna Raye Mason
Privacy Of Information And Dna Testing Kits, Shanna Raye Mason
Catholic University Journal of Law and Technology
In modern times, consumers desire for more control over their own health and healthcare. With this growing interest of control, direct to consumer DNA testing kits have never been more popular. However, many consumers are unaware of the potential privacy concerns associated with such use. This comment examines the popularity and privacy risks that are likely unknown to the individual consumer. This comment also addresses the shortcomings of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Genetic Information Nondiscrimination Act of 2008 (GINA) in regard to protecting individual’s genetic information from misuse. This comment …
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Michigan Law Review
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …
Drug Pricing—The Next Compliance Waterloo, Seth Whitelaw, Nicodemo Fiorentino, Jennifer O'Leary
Drug Pricing—The Next Compliance Waterloo, Seth Whitelaw, Nicodemo Fiorentino, Jennifer O'Leary
Mitchell Hamline Law Review
No abstract provided.
Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck
Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck
SMU Science and Technology Law Review
No abstract provided.
Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines
Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines
Nevada Law Journal
No abstract provided.
Utilizing Adr As A Vehicle For Effective Communication And Success Of Payment In Urgent Care, Stephanie R. Goldberg
Utilizing Adr As A Vehicle For Effective Communication And Success Of Payment In Urgent Care, Stephanie R. Goldberg
Cardozo Journal of Conflict Resolution
Section II of this Note provides background on urgent care and ADR. Section III will elaborate on current payment procedures and explain some of the pitfalls that create a need for a supplementary payment solution. Section IV lays out a four-step plan incorporating a logical progression of ADR techniques that would enable quality of care and ease and success of financial arrangements, and vastly improved patient-provider relations. The feasibility of this plan will be demonstrated through application of its steps to hypothetical examples, representative of various realistic patient experiences, in Section V. This plan is intended to aid the millions …
Using The Public Nuisance Doctrine To Combat Antibiotic Resistance, Amanda Purcell
Using The Public Nuisance Doctrine To Combat Antibiotic Resistance, Amanda Purcell
American University Law Review
No abstract provided.
Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik
Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik
Vanderbilt Journal of Entertainment & Technology Law
How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Faculty Publications By Year
There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …
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 …
Small Sustainability Supply: How Small Business And Lean Manufacturing Can Change Supply Chains, Carlos Lopez
Small Sustainability Supply: How Small Business And Lean Manufacturing Can Change Supply Chains, Carlos Lopez
Sustainable Development Law & Policy
No abstract provided.
Benefitting From Sustainable Development, Victoria Frappaolo
Benefitting From Sustainable Development, Victoria Frappaolo
Sustainable Development Law & Policy
No abstract provided.
Batteries Included: Incentivizing Energy Storage, Lindsay Breslau, Michael Croweak, Alan Witt
Batteries Included: Incentivizing Energy Storage, Lindsay Breslau, Michael Croweak, Alan Witt
Sustainable Development Law & Policy
Distributed Energy Storage (“DES”) technologies that allow households and businesses to store substantial amounts of electricity on site are rapidly advancing and could soon have dramatic impacts on the nation’s electricity generation, transmission, and distribution markets. These technologies could provide numerous benefits, including enhanced energy security, grid stability, and greater support for renewable generation technologies, but several obstacles are slowing their adoption throughout the country. Among these obstacles are stubbornly high manufacturing costs and the potential impacts of DES development on utilities and the traditional energy regulatory framework. Fortunately, policymakers in California, New York, Hawaii, and some other states are …
Appraising The Role Of The Ifc And Its Independent Accountability Mechanism: Community Experiences In Haiti’S Mining Sector, Kate Nancy Taylor
Appraising The Role Of The Ifc And Its Independent Accountability Mechanism: Community Experiences In Haiti’S Mining Sector, Kate Nancy Taylor
Sustainable Development Law & Policy
No abstract provided.
Green Is Good: How Green Bonds Cultivated Into Wall Street’S Environmental Paradox, Luke Trompeter
Green Is Good: How Green Bonds Cultivated Into Wall Street’S Environmental Paradox, Luke Trompeter
Sustainable Development Law & Policy
When the European Investment Bank issued the first green bond in 2007, few imagined this debt instrument would attract mainstream investors. Designed to finance projects ranging from climate change prevention to clean transportation development, green bonds were geared for socially responsible investors concerned with our planet’s sustainability. However, by 2015, green bonds were issued by major corporations like Apple and municipalities like New York City at a record $40 billion. Major players on Wall Street have taken notice and look to cash in on the rapidly growing green bond market. With this new influx of investment and the bonds’ tax-exempt …
Editor's Note, Kimberly Reynolds, Ryan Schmidt
Editor's Note, Kimberly Reynolds, Ryan Schmidt
Sustainable Development Law & Policy
No abstract provided.
Can The Eu Carbon Tax The U.S. In Retaliation?, Annum Rashedi
Can The Eu Carbon Tax The U.S. In Retaliation?, Annum Rashedi
Sustainable Development Law & Policy
No abstract provided.
Regional Disputes: It Is Not Just Ground Beef, Nicholas W. Laneville
Regional Disputes: It Is Not Just Ground Beef, Nicholas W. Laneville
Sustainable Development Law & Policy
No abstract provided.
Fighting The Wrong Fight: Why The Mlp Parity Act Is A Misguided Attempt At Achieving Renewable Energy Capital Raising Parity, David Powers
Fighting The Wrong Fight: Why The Mlp Parity Act Is A Misguided Attempt At Achieving Renewable Energy Capital Raising Parity, David Powers
Sustainable Development Law & Policy
No abstract provided.
The Paris Agreement And The International Trade Regime: Considerations For Harmonization, Charles E. Di Leva, Xiaoxin Shi
The Paris Agreement And The International Trade Regime: Considerations For Harmonization, Charles E. Di Leva, Xiaoxin Shi
Sustainable Development Law & Policy
No abstract provided.
Never For-Gatt: What Recent Tbt Decisions Reveal About The Appellate Body’S Analysis Of Environmental Regulation Under The Wto Agreements, Ravi Soopramanien
Never For-Gatt: What Recent Tbt Decisions Reveal About The Appellate Body’S Analysis Of Environmental Regulation Under The Wto Agreements, Ravi Soopramanien
Sustainable Development Law & Policy
Few environmentalists have positive things to say on the impact of the World Trade Organization (WTO) on the environment. WTO legal obligations are frequently cited as the most significant impediment to a range of environmental initiatives, including notably meaningful international coordination to combat climate change, particularly through carbon tax initiatives, and imposition of electronic waste disposal export bans. In this vein, adverse findings of WTO dispute panels on environmental conservation measures tend to attract the ire of international civil society. The tensions between liberal trade and environmental protection can be traced back to the days of the General Agreement on …