An outsiders viewpoint: The FDA should regulate clinical pharmacogenetic/genomic tests, but.

Clinical Pharmacology and Therapeutics

Volumn 88, Issue 6, 2010, Pages 746-748

  O'Kane, D ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL EVALUATION; CLINICAL GENETICS; FOOD AND DRUG ADMINISTRATION; GENETIC SCREENING; GENOMICS; HUMAN; PATIENT CARE; PHARMACOGENETICS; PRIORITY JOURNAL; RISK ASSESSMENT; SHORT SURVEY; LEGAL ASPECT; NOTE; REPRODUCIBILITY; UNITED STATES;

GENETIC TESTING; GENOMICS; HUMANS; PHARMACOGENETICS; REPRODUCIBILITY OF RESULTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 78449291909     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2010.235     Document Type: Short Survey

References (10)

1. US Food and Drug Administration. FDA to host public meeting on oversight of laboratory-developed tests (16 June 2010).
2. US House of Representatives. Genomics and Personalized Medicine Act of 2010 (27 May 2010).
3. Turna, R. Draft bill proposes FDA create new division to review "advanced personalized diagnostics." Pharmacogenomics Reporter, 23
4. June 2010 http://www.genomeweb.com//node/943707?hq-e=el&hq-m= 751234&hq-l=1&hq-v=c8e9e4a700>. June 2010 .
5. US Food and Drug Administration. Sec. 201 [21 U.S.C. 321] Chapter II-Definitions (13 July 2009).
6. US Food and Drug Administration. FDA to hold daylong meeting on medical device innovation (21 June 2010).
7. US Food and Drug Administration. Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System-Guidance for Industry and FDA Staff (10 March 2005).
8. Hamburg, M.A. & Collins, F.S. The path to personalized medicine. N. Engl. J. Med. 363, 1092 (2010).
9. College of American Pathologists. Proposed Approach to Oversight of Laboratory Developed Tests (28 April 2010).
10. US Food and Drug Administration. Quality Systems Regulation (14 June 2010).