Clash of the Titans: Conflicts in the Regulation of Medical Devices by the FDA and PTO

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Clash of the Titans: Conflicts in the Regulation of Medical Devices by the FDA and PTO

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Lazebnik, Ron en_US
dc.date.accessioned 2012-12-07T15:13:35Z
dc.date.issued 2005 en_US
dc.identifier.citation Clash of the Titans: Conflicts in the Regulation of Medical Devices by the FDA and PTO (2005 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:10015267
dc.description.abstract This paper discusses two of the conflicts created by the fact that both the Food and Drug Administration and the Patent and Trademark Office regulate medical devices and drugs. A brief description of the two agencies is made to give a sense of their goals and of their resources involved. The conflicts discussed are the effect each agency has on the monopolistic power a company may have in the market, and the problem arising from the term “substantial equivalence†being used by the agencies for very contrary goals. With each conflict, the method to resolve the problem is discussed, be it by acts of Congress, the Courts, or the industry itself. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject FDA en
dc.subject PTO en
dc.title Clash of the Titans: Conflicts in the Regulation of Medical Devices by the FDA and PTO en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-12-07T15:13:35Z

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