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

DSpace/Manakin Repository

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