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See Latest ArticlesPrice, Performance, and the FDA Approval Process: The Example of Home HIV Testing
Medical Decision Making, 05/11/09
Paltiel AD et al. - The analytic framework produces the elementary but counterintuitive finding that the performance of the home HIV test— measured in terms of its ability to correctly detect the presence and absence of HIV infection among the people who purchase it—depends critically on the manufacturer’s retail price. This finding has profound implications for the FDA’s approval process.
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