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dc.contributor.advisorHutt, Peter Bartonen_US
dc.contributor.authorZablow, Sheilaen_US
dc.date.accessioned2012-12-07T16:18:43Z
dc.date.issued1996en_US
dc.identifier.citationThe LARS: A Proposed Approach for FDA Evaluation of Home Testing Products (1996 Third Year Paper)en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:10015316
dc.description.abstractThis 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.isoen_USen
dash.licenseLAAen_US
dc.subjectFood and Drug Lawen
dc.subjecthome testingen
dc.subjectHIVen
dc.subjecthome testing kitsen
dc.titleThe LARS: A Proposed Approach for FDA Evaluation of Home Testing Productsen
dc.typePaper (for course/seminar/workshop)en_US
dc.date.available2012-12-07T16:18:43Z
dash.authorsorderedfalse


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