Understanding FDA regulation of DTC genetic tests within the context of administrative law |
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Authors: | Wagner Jennifer K |
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Affiliation: | 1 Institute for Genome Sciences and Policy, Duke University, Durham, NC 27708, U.S.A |
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Abstract: | How the FDA should regulate direct-to-consumer genetic tests is fiercely contested. Passing a rule or issuing an order is only one down in the series. There is more to the regulatory game. |
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