Laboratory-developed tests are not the practice of medicine
- PMID: 26495599
Laboratory-developed tests are not the practice of medicine
Similar articles
-
US Food and Drug Administration regulatory oversight of laboratory-developed tests: Commentary on the draft guidance.Cancer Cytopathol. 2015 Oct;123(10):573-5. doi: 10.1002/cncy.21566. Epub 2015 Jun 4. Cancer Cytopathol. 2015. PMID: 26042383 No abstract available.
-
FDA oversight of laboratory-developed tests will facilitate adoption of pharmacogenetic testing into routine clinical care.J Clin Pharmacol. 2015 Jul;55(7):728-30. doi: 10.1002/jcph.521. J Clin Pharmacol. 2015. PMID: 26053648 No abstract available.
-
FDA's draft guidance on laboratory-developed tests increases clinical and economic risk to adoption of pharmacogenetic testing.J Clin Pharmacol. 2015 Jul;55(7):725-7. doi: 10.1002/jcph.492. J Clin Pharmacol. 2015. PMID: 26053647 Free PMC article. No abstract available.
-
Understanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food, Drug, and Cosmetic Act-Regulated and Clinical Laboratory Improvement Amendments of 1988-Regulated Activities.Clin Lab Med. 2016 Sep;36(3):575-85. doi: 10.1016/j.cll.2016.05.005. Epub 2016 Jun 30. Clin Lab Med. 2016. PMID: 27514469 Review.
-
Laboratory-Developed Tests: A Legislative and Regulatory Review.Clin Chem. 2017 Oct;63(10):1575-1584. doi: 10.1373/clinchem.2017.275164. Epub 2017 Jul 7. Clin Chem. 2017. PMID: 28687634 Review.
Cited by
-
Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.J Mol Diagn. 2021 Oct;23(10):1207-1217. doi: 10.1016/j.jmoldx.2021.07.011. Epub 2021 Sep 16. J Mol Diagn. 2021. PMID: 34538703 Free PMC article. Review.
MeSH terms
LinkOut - more resources
Medical