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Full-Text Articles in Law
The Myths Of Data Exclusivity, Erika Lietzan
The Myths Of Data Exclusivity, Erika Lietzan
Faculty Publications
This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …
Drugs, Drugs Everywhere But Just Not For The Poor, Srividhya Ragavan
Drugs, Drugs Everywhere But Just Not For The Poor, Srividhya Ragavan
Faculty Scholarship
The objective for this article is to understand the legitimacy and limitations of US involvement in another country’s sovereign actions taken expressly in the public interest, or to protect public health, such as the compulsory licensing of pharmaceuticals.