Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine

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Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Fahnestock, Derek en_US
dc.date.accessioned 2012-06-15T20:53:04Z
dc.date.issued 2005 en_US
dc.identifier.citation Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine (2005 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8889482
dc.description.abstract Pharmacogenomic technologies promise to usher in an era of individualized medicine, but also pose challenges to a regulatory regime without experience dealing with the sorts of data produced by these techniques. Pharmacogenomics as a field encompasses both pharmacogenetic techniques, which tend to focus on polymorphisms in cytochromes and other proteins involved in drug metabolism, and pharmacogenomic techniques such as microarray technologies, which examine disease and drug interactions on the level of the entire genome. In 2003, the FDA produced a guidance recommending procedures for the submission of pharmacogenomic data at the IND or NDA stage. While pharmacogenomic information used in decision making; during trials is required, most pharmacogenomic data of an exploratory nature may be submitted voluntarily under a separate protocol. Though these procedures seem a reasonable means by which the FDA can open a dialogue with pharmaceutical manufacturers regarding the use of pharmacogenomic data, more action is necessary to develop the infrastructure necessary to develop the technology such that in may be incorporated in regulatory decisions with confidence. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject pharmacogenomics en
dc.title Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-15T20:53:04Z

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