An outsider's viewpoint: the FDA should regulate clinical pharmacogenetic/genomic tests, but....
Clinical pharmacology and therapeutics 2010 Dec; 88(6): 746-8
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Evans, B J (2010-12)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 ...
Lynn, Joanne; Baily, Mary Ann; Bottrell, Melissa; Jennings, Bruce; Levine, Robert J.; Davidoff, Frank; Casarett, David; Corrigan, Janet; Fox, Ellen; Wynia, Matthew K.; Agich, George J.; O'Kane, Margaret; Speroff, Theodore; Schyve, Paul; Batalden, Paul; Tunis, Sean; Berlinger, Nancy; Cronenwett, Linda; Fitzmaurice, J. Michael; Neveloff Dubler, Nancy; James, Brent (2007-05-01)Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations ...