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

Clinical Pharmacology and Therapeutics

Volumn 88, Issue 6, 2010, Pages 749-751

  Evans, B J ^a  

^a UNIVERSITY OF HOUSTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIAGNOSTIC TEST; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; HEALTH CARE POLICY; LAW ENFORCEMENT; NOTE; PHARMACOGENETICS; PHARMACOGENOMICS; PRIORITY JOURNAL;

ANIMALS; GENETIC TESTING; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78449297726     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.237     Document Type: Note

References (12)

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2. US Department of Health and Human Services, Food and Drug Administration. Oversight of laboratory developed tests. Fed. Reg. 75, 34,463-34,464 (17 June 2010).
3. US Department of Health and Human Services. Secretary's Advisory Committee on Genetics, Health, and Society. US System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services http://oba.od.nih.gov/oba/SACGHS/reports/SACGHS-oversight-report.pdf> (2008).
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7. US, Department of Health and Human Services, Food and Drug Administration. FDA's Sentinel Initiative, http://www.fda.gov/Safety/ FDAsSentinelInitiative/default.htm.
8. Evans, B.J. Authority of the Food and Drug Administration to require data access and control use rights in the Sentinel data network. Food & Drug Law J. 65, 67-112 (2010).
9. US Food and Drug Administration. FDA announces new boxed warning on Plavix [press release] (12 March 2010).
10. US Food and Drug Administration. Postmarket Drug Safety Information for Patients and Providers .
11. US, Department of Health and Human Services, Food and Drug Administration. Approved Risk Evaluation and Mitigation Strategies (REMS), http://www.fda.gov/Drugs/DrugSafety/ PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm> (2010). Accessed 23 June 2010.
12. Crosley, S. Potential for personalized medicine and accessible data for research, slide 7, in Protecting Privacy in Health Research Critical Issues Workshop Proceedings. Center for Applied Cybersecurity Research, Indiana University (11 August 2010).