148 related articles for article (PubMed ID: 23091959)
1. Laboratory developed tests: what may be coming.
Jones PM
MLO Med Lab Obs; 2012 Oct; 44(10):24, 26. PubMed ID: 23091959
[No Abstract] [Full Text] [Related]
2. Tighter gene tests.
Fox J
Nat Biotechnol; 2008 Jul; 26(7):721. PubMed ID: 18612277
[No Abstract] [Full Text] [Related]
3. US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.
Sidawy MK
Cancer Cytopathol; 2015 Oct; 123(10):573-5. PubMed ID: 26042383
[No Abstract] [Full Text] [Related]
4. Laboratory-developed tests are not the practice of medicine.
Allen JS
MLO Med Lab Obs; 2015 Sep; 47(9):46. PubMed ID: 26495599
[No Abstract] [Full Text] [Related]
5. FDA regulation of laboratory-developed diagnostic tests: protect the public, advance the science.
Sharfstein J
JAMA; 2015 Feb; 313(7):667-8. PubMed ID: 25560381
[No Abstract] [Full Text] [Related]
6. Regulating laboratory-developed tests: devil will be in details.
McNeil C
J Natl Cancer Inst; 2015 Apr; 107(4):. PubMed ID: 25838442
[No Abstract] [Full Text] [Related]
7. FDA regulation of LDTs--an update.
Jones PM
MLO Med Lab Obs; 2015 Sep; 47(9):18-9. PubMed ID: 26495591
[No Abstract] [Full Text] [Related]
8. FDA announces plans to regulate LDTs.
Cancer Discov; 2014 Nov; 4(11):1250. PubMed ID: 25367935
[No Abstract] [Full Text] [Related]
9. 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]
10. Looming regulations and FDA oversight mean an uncertain reimbursement climate in 2016.
Wolf R
MLO Med Lab Obs; 2016 May; 48(5):26-7. PubMed ID: 27323455
[No Abstract] [Full Text] [Related]
11. The long and winding regulatory road for laboratory-developed tests.
Weiss RL
Am J Clin Pathol; 2012 Jul; 138(1):20-6. PubMed ID: 22706853
[TBL] [Abstract][Full Text] [Related]
12. The regulation of sanitary food transportation in the United States: a slow journey on a long road.
Miller JA
Food Drug Law J; 2008; 63(1):35-73. PubMed ID: 18561454
[No Abstract] [Full Text] [Related]
13. Talking with Randy Daniel. Interview by Celia Stevens.
Daniel R
MLO Med Lab Obs; 2003 Jan; 35(1):22-3. PubMed ID: 12561742
[No Abstract] [Full Text] [Related]
14. The role and activities of the ISCT Regulatory Affairs Committee.
Kelley L
Cytotherapy; 2003; 5(4):279-83. PubMed ID: 12944232
[TBL] [Abstract][Full Text] [Related]
15. Looking abroad: clinical drug trials.
Hathaway CR; Manthei JR; Haas JB; Scherer CA
Food Drug Law J; 2008; 63(3):673-81. PubMed ID: 19031667
[No Abstract] [Full Text] [Related]
16. Anticipating new consumer protection challenges in the food and drug marketplace.
Parnes LB
Food Drug Law J; 2008; 63(2):593-9. PubMed ID: 18561480
[No Abstract] [Full Text] [Related]
17. US Food and Drug Administration-approved laboratory tests after Caronia.
Allen TC
Arch Pathol Lab Med; 2013 Nov; 137(11):1543-4. PubMed ID: 23495756
[No Abstract] [Full Text] [Related]
18. Counterpoint: Why the FDA Should Not Regulate Laboratory-Developed Tests.
Leung ML
J Appl Lab Med; 2024 Jan; 9(1):155-158. PubMed ID: 38167755
[No Abstract] [Full Text] [Related]
19. Premarket approval regulation for lie detections: an idea whose time may be coming.
Greely HT
Am J Bioeth; 2005; 5(2):50-2; discussion W5. PubMed ID: 16036701
[No Abstract] [Full Text] [Related]
20. 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]
[Next] [New Search]
