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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| Published in | Clinical pharmacology and therapeutics Vol. 88; no. 6; p. 749 |
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| Main Author | |
| Format | Journal Article |
| Language | English |
| Published |
United States
01.12.2010
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| Subjects | |
| Online Access | Get more information |
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| Abstract | 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. |
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| AbstractList | 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. |
| Author | Evans, B J |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/21081943$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | 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 |
| Title | Establishing clinical utility of pharmacogenetic tests in the post-FDAAA era |
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