199 related articles for article (PubMed ID: 28557601)
1. 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]
2. US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.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]
3. 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]
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. 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]
6. 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]
7. FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care.
Hillebrenner E; Litwack E; Bradley P; Donigan K; Lowe T; Serrano K; Kelm K; Mansfield E; Gutierrez A
J Clin Pharmacol; 2015 Jul; 55(7):728-30. PubMed ID: 26053648
[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. Code of Federal Regulations (CFRs): where it all begins.
Kreuger J; Stengl A; Skalitzky D; Wehmeyer P
Qual Assur; 1994 Mar; 3(1):82-7. PubMed ID: 7804622
[No Abstract] [Full Text] [Related]
10. 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]
11. FDA and clinical labs: beginning a dialogue.
Javitt G
MLO Med Lab Obs; 2007 May; 39(5):52, 50. PubMed ID: 18396740
[No Abstract] [Full Text] [Related]
12. 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]
13. 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]
14. "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]
15. FDA Announces Increased Oversight of Some Diagnostic Laboratory Tests.
Harris E
JAMA; 2024 Jun; 331(24):2071. PubMed ID: 38819803
[No Abstract] [Full Text] [Related]
16. Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests.
D'Angelo R; Weiss R; Wolfe D; Chinnam R; Murat A; Gluesing J; Somers T
Am J Clin Pathol; 2018 Apr; 149(6):484-498. PubMed ID: 29659675
[TBL] [Abstract][Full Text] [Related]
17. Compounding oversight a work in progress for states, FDA.
Traynor K
Am J Health Syst Pharm; 2016 Apr; 73(7):424-5. PubMed ID: 27001978
[No Abstract] [Full Text] [Related]
18. 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]
19. A comparison of the U.S. EPA FIFRA GLP standards with the U.S. FDA GLP standards for nonclinical laboratory studies.
Keatley KL
Qual Assur; 1999; 7(3):147-54. PubMed ID: 11033740
[TBL] [Abstract][Full Text] [Related]
20. FDA set to tighten guidelines on industry dissemination of information on unapproved uses of medical products.
Lang L
Gastroenterology; 2008 Apr; 134(4):905. PubMed ID: 18395067
[No Abstract] [Full Text] [Related]
[Next] [New Search]