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

• Published in: Clinical pharmacology and therapeutics Vol. 88; no. 6; p. 749
• Main Author: Evans, B J
• Format: Journal Article
• Language: English
• 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

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...