255 related articles for article (PubMed ID: 20578940)
1. FDA and CLIA oversight of advanced diagnostics and biomarker tests.
Terry SF
Genet Test Mol Biomarkers; 2010 Jun; 14(3):285-7. PubMed ID: 20578940
[No Abstract] [Full Text] [Related]
2. Modification of In Vitro Diagnostic Devices: Leveling the Playing Field.
Rychert J; Delgado JC; Genzen JR
Clin Chem; 2020 Jun; 66(6):760-762. PubMed ID: 32278318
[No Abstract] [Full Text] [Related]
3. Finding control in quality control of unit-use prothrombin time tests.
Pontius CA
MLO Med Lab Obs; 2001 May; 33(5):38-40, 42. PubMed ID: 11373813
[No Abstract] [Full Text] [Related]
4. FDA oversight of laboratory-developed tests: is it necessary, and how would it impact clinical laboratories?
Scott MG; Ashwood ER; Annesley TM; Leonard DG; Burgess MC
Clin Chem; 2013 Jul; 59(7):1017-22. PubMed ID: 23536512
[No Abstract] [Full Text] [Related]
5. New HDL-cholesterol reagent formulation reduces interference from samples with abnormal proteins.
Hoefner DM
Clin Chim Acta; 2006 Dec; 374(1-2):142-4. PubMed ID: 16701600
[No Abstract] [Full Text] [Related]
6. Ensuring quality in genomic medicine: amid the rise in complex laboratory-developed tests, regulatory officials are seeking the right balance on quality assurance.
Nelson B
Cancer Cytopathol; 2014 Dec; 122(12):855-6. PubMed ID: 25510938
[No Abstract] [Full Text] [Related]
7. Perspective for the development of companion diagnostics and regulatory landscape to encourage personalized medicine in Japan.
Tazawa Y
Breast Cancer; 2016 Jan; 23(1):19-23. PubMed ID: 25605056
[TBL] [Abstract][Full Text] [Related]
8. SIMD commentary on FDA oversight of laboratory-developed testing.
Vladutiu GD
Mol Genet Metab; 2011 Jan; 102(1):1-3. PubMed ID: 21130673
[No Abstract] [Full Text] [Related]
9. How will the FDA impact the laboratory developed test?
Davis J; Wentz J
Clin Lab Sci; 2007; 20(3):130-1. PubMed ID: 17691668
[No Abstract] [Full Text] [Related]
10. "Research use only" reagents: is there an imperative for increased FDA oversight?
O'Leary TJ
Clin Chem; 2011 Dec; 57(12):1681-3. PubMed ID: 21998341
[No Abstract] [Full Text] [Related]
11. FDA Oversight of Laboratory-Developed Tests: Where Are We Now?
Gatter K
Arch Pathol Lab Med; 2017 Jun; 141(6):746-748. PubMed ID: 28557601
[No Abstract] [Full Text] [Related]
12. FDA halts 23andMe personal genetic tests. What might this mean for the future of direct-to-consumer testing?
Darnovsky M; Cussins J
MLO Med Lab Obs; 2014 Mar; 46(3):33. PubMed ID: 24696953
[No Abstract] [Full Text] [Related]
13. News from the latest CLIAC meeting.
Pontius CA
MLO Med Lab Obs; 2001 Jul; 33(7):38-40. PubMed ID: 11467173
[No Abstract] [Full Text] [Related]
14. Multigene classifiers, prognostic factors, and predictors of breast cancer clinical outcome.
Ross JS
Adv Anat Pathol; 2009 Jul; 16(4):204-15. PubMed ID: 19546609
[TBL] [Abstract][Full Text] [Related]
15. The US Food and Drug Administration perspective on cancer biomarker development.
Gutman S; Kessler LG
Nat Rev Cancer; 2006 Jul; 6(7):565-71. PubMed ID: 16794639
[TBL] [Abstract][Full Text] [Related]
16. The FDA is coming! The FDA is coming!
Leonard DG
Mol Diagn; 2001 Sep; 6(3):153-4. PubMed ID: 11571707
[No Abstract] [Full Text] [Related]
17. Good laboratory practices for molecular genetic testing for heritable diseases and conditions.
Chen B; Gagnon M; Shahangian S; Anderson NL; Howerton DA; Boone JD;
MMWR Recomm Rep; 2009 Jun; 58(RR-6):1-37; quiz CE-1-4. PubMed ID: 19521335
[TBL] [Abstract][Full Text] [Related]
18. C-Path sets diagnostics standard.
Roberts J
Nat Biotechnol; 2009 Mar; 27(3):213. PubMed ID: 19270654
[No Abstract] [Full Text] [Related]
19. [Procedure for accurate evaluation of laboratory data and its international trends].
Kuwa K
Rinsho Byori; 2005 Jun; 53(6):531-9. PubMed ID: 16026081
[TBL] [Abstract][Full Text] [Related]
20. FDA approves genetic test for women with breast cancer.
Josefson D
BMJ; 1998 Jan; 316(7126):168. PubMed ID: 9468672
[No Abstract] [Full Text] [Related]
[Next] [New Search]
