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Articles 1 - 4 of 4
Full-Text Articles in Law
An Overview Of Progress In The International Regulation Of The Pharmaceutical Industry, Joan Costa-Font, Aaron Burakoff Harvard University; University Of Barcelona
An Overview Of Progress In The International Regulation Of The Pharmaceutical Industry, Joan Costa-Font, Aaron Burakoff Harvard University; University Of Barcelona
The University of New Hampshire Law Review
[Excerpt] “The pharmaceutical industry, a significant source of healthcare throughout the world, has several features that distinguish it from the rest of the health industry. In the last half-century, new technology, better technological know-how, and overall economic growth have led to widespread and rapid growth in the pharmaceutical sector. Advancements in pharmaceutical research and development have led to the production of drugs that can routinely combat afflictions that, only years ago, were untreatable or even fatal. Since 1970, the average share of Gross Domestic Product (GDP) on pharmaceutical goods has increased in most Organization for Economic Cooperation and Development (OECD) …
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston P. Nagan
International Intellectual Property, Access To Health Care, And Human Rights: South Africa V. United States, Winston P. Nagan
UF Law Faculty Publications
This Article examines the question of access to patented medicines in international law. It analyzes the extent to which international agreements may lawfully limit affordable versions of these medicines that may be available through parallel imports or compulsory licensing procedures. It considers the concept of intellectual property rights from a national and international perspective to determine how these rights must be sensitive to matters of national sovereignty when extraordinary, life-threatening diseases afflict societies in catastrophic ways. This Article suggests that viewing property (including intellectual property) as a human right requires that its scope be delimited and understood in the context …
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
Book Chapters
The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …