The LARS: A Proposed Approach for FDA Evaluation of Home Testing Products

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The LARS: A Proposed Approach for FDA Evaluation of Home Testing Products

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Zablow, Sheila en_US
dc.date.accessioned 2012-12-07T16:18:43Z
dc.date.issued 1996 en_US
dc.identifier.citation The LARS: A Proposed Approach for FDA Evaluation of Home Testing Products (1996 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:10015316
dc.description.abstract This paper critiques the manner in which the Food and Drug Administration uses its discretionary authority to regulate the sale of home testing products. Part I provides the legal framework for FDA approval of home testing products and emphasizes the discretionary authority enjoyed by the agency. In particular, Part I details the responsibility of the FDA to ensure that marketed devices are both safe and effective. Part II details the manner in which the FDA has used its discretionary authority to prevent the sale of HIV blood collection kits. It supports the argument that the current system of regulation is marked by the FDA's excessive use of its statutory discretion. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject home testing en
dc.subject HIV en
dc.subject home testing kits en
dc.title The LARS: A Proposed Approach for FDA Evaluation of Home Testing Products en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-12-07T16:18:43Z

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