Establishing clinical utility of pharmacogenetic tests in the post-FDAAA era

The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have long im...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 88; no. 6; p. 749
Main Author Evans, B J
Format Journal Article
LanguageEnglish
Published United States 01.12.2010
Subjects
Animals
Genetic Testing - legislation & jurisprudence
Genetic Testing - standards
Genetic Testing - trends
Humans
Pharmaceutical Preparations - standards
Pharmacogenetics - legislation & jurisprudence
Pharmacogenetics - standards
Pharmacogenetics - trends
United States
United States Food and Drug Administration - legislation & jurisprudence
United States Food and Drug Administration - standards
United States Food and Drug Administration - trends
United States
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Summary:The US Food and Drug Administration (FDA) Amendments Act of 2007, when fully implemented, will offer new sources of evidence and new regulatory mechanisms during the postmarket phase of drug life. If artfully and carefully applied, these new capabilities could help resolve problems that have long impeded the clinical translation of pharmacogenomics.
ISSN:1532-6535
DOI:10.1038/clpt.2010.237