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Articles 31 - 36 of 36
Full-Text Articles in Food and Drug Law
Promoting Ethical Standards In Globalized Drug Trials Through Market Exclusion, Fazal Khan
Promoting Ethical Standards In Globalized Drug Trials Through Market Exclusion, Fazal Khan
Popular Media
With the increasing accessibility of cheap internet communication, human research subjects and concerned citizens in developing nations can be empowered to effectuate much of the surveillance and monitoring activities of clinical drug trials. For instance, WHO could maintain a multilingual website for the reporting of alleged ethical violations. A credible report could then prompt WHO officials to obtain a sworn statement from the reporter, which would then trigger an investigation into the alleged ethical abuses. Verified reports of ethical abuses can then be taken into account by drug regulatory agencies when determining whether a drug should obtain market approval.
Putting The Brakes On Drugs: The Impact Of Ksr V. Teleflex On Pharmaceutical Patenting Strategies, Diane C. Renbarger
Putting The Brakes On Drugs: The Impact Of Ksr V. Teleflex On Pharmaceutical Patenting Strategies, Diane C. Renbarger
Georgia Law Review
In its 2007 KSR v. Teleflex decision, the Supreme Court permitted KSR International Co. to manufacture an adjustable gas pedal in spite of a competitor's patent. The ruling struck down the Federal Circuit's test to determine whether a patent is obvious and thereby invalid. Since the decision, there has been speculation about how much, if at all, the Supreme Court's decision changed patent validity standards,and particularly about how the decision will influence pharmaceutical patenting. This Note examines the impact KSRv. Teleflex may have on the pharmaceutical industry. Pharmaceutical patenting laws and early court decisions applying the reasoning of KSR v. …
A Penny For Your Thoughts: Private And Collective Contracting For Traditional Medicinal Knowledge Modeled On Bioprospecting Contracts In Costa Rica, Katie Bates
Georgia Law Review
For decades, pharmaceutical companies have prospected biologically diverse developing countries for plants and molecules that may form the foundations of groundbreaking medicines. In many cases, native populations have aided researchers by directing them to the plants used in their traditional medicines. Only recently, however, have native peoples pushed for compensation for this valuable contribution. The governments of developing countries, too, have begun to assert legal and physical control over their natural resources, making access to these resources by pharmaceutical companies more difficult and costly. Simultaneously, scientific developments have made drug discovery through alternative methods more feasible. Despite these changes, it …
The Plan B For Plan B: The New Dual Over-The-Counter And Prescription Status Of Plan B And Its Impact Upon Pharmacists, Consumers, And Conscience Clauses, Brittany L. Grimes
The Plan B For Plan B: The New Dual Over-The-Counter And Prescription Status Of Plan B And Its Impact Upon Pharmacists, Consumers, And Conscience Clauses, Brittany L. Grimes
Georgia Law Review
On August 24,2006, the U.S. Food and Drug Administration decided to approve Plan B, the "morning-after"contraceptive pill, as an over-the-counter drug for women ages eighteen and older only. Individuals aged seventeen years and younger must still obtain a prescription in order to purchase Plan B, resulting in confusion and complications in implementing the age limitation. Additionally, the dual status of Plan B as both a prescription and over-the-counter drug might still be undermined by pharmacists choosing to refuse sale of contraceptives under various state protective conscience clauses. This Note explores the impact of the FDA's novel decision to create a …
Trans Fat: Can New York City Save Its Citizens From This "Metabolic Poison"?, Elizabeth Y. Spivey
Trans Fat: Can New York City Save Its Citizens From This "Metabolic Poison"?, Elizabeth Y. Spivey
Georgia Law Review
Trans fat was developed by chemists at the turn of the century and became an increasingly large part of the American diet. Trans fat in the form of partially hydrogenated vegetable oil now makes up 2% of all calories consumed in the United States. In the past two decades, studies have shown that artificially created trans fat increases cholesterol and increases the risk of coronary heart disease, heart attack, and type II diabetes. In response to these health concerns, New York City's Board of Health voted to ban trans fat from restaurant fare in December 2006. Other cities and local …
The Regulation Of Medical Devices: A Comparative Study Of American And Eec Law, Martine Carliese Pijnappels
The Regulation Of Medical Devices: A Comparative Study Of American And Eec Law, Martine Carliese Pijnappels
LLM Theses and Essays
Part I of this thesis will describe the regulation of medical devices in the EEC. Before coming to the actual medical device legislation, a description of the legislative system in Europe will be given, to the extent that it is relevant for the Directives on medical devices. After dealing with the history of Directives and their current contents, the status of the Directives and their future prospects will be discussed. Part II will deal with the regulation of medical devices in the United States under the Food Drug & Cosmetic Act as amended by Medical Device Amendments of 1976. First, …