美国食品药品监督管理局与基因检测 - Suppr

Suppr

超能文献

The FDA and genetic testing.

作者信息

Litwack E David, Mansfield Elizabeth, Shuren Jeffrey

机构信息

Food and Drug Administration, Silver Spring, MD.

出版信息

N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27.

DOI:10.1056/NEJMc1504604

PMID:26014594

Abstract

摘要

相似文献

The FDA and genetic testing.

N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27.

The FDA and genomic tests--getting regulation right.

N Engl J Med. 2015 Jun 4;372(23):2258-64. doi: 10.1056/NEJMsr1501194. Epub 2015 May 27.

In search of a coherent framework: options for FDA oversight of genetic tests.

Food Drug Law J. 2007;62(4):617-52.

Regulating genetic tests: issues that guide policy decisions.

Genet Test Mol Biomarkers. 2012 Jan;16(1):1-2. doi: 10.1089/gtmb.2011.1527.

Policy implications of genetic testing: not just for geneticists anymore.

Adv Chronic Kidney Dis. 2006 Apr;13(2):178-82. doi: 10.1053/j.ackd.2006.01.003.

Genetic testing and FDA regulation: overregulation threatens the emergence of genomic medicine.

JAMA. 2015 Feb 17;313(7):669-70. doi: 10.1001/jama.2014.18145.

Pharmacogenetics and ethical considerations: why care?

Pharmacogenomics J. 2007 Oct;7(5):293-6. doi: 10.1038/sj.tpj.6500425. Epub 2006 Oct 10.

Standards and controls for genetic testing.

Cancer Biomark. 2005;1(4-5):217-20. doi: 10.3233/cbm-2005-14-503.

The incorporation of new technologies into genetic services; the importance of government support.

Birth Defects Orig Artic Ser. 1992;28(3):126-30.

Molecular medicine: how, what, and when?

Clin Pharmacol Ther. 2007 Oct;82(4):376-8. doi: 10.1038/sj.clpt.6100349.

引用本文的文献

The need for polygenic score reporting standards in evidence-based practice: lipid genetics use case.

Curr Opin Lipidol. 2021 Apr 1;32(2):89-95. doi: 10.1097/MOL.0000000000000733.

Payer Coverage for Hereditary Cancer Panels: Barriers, Opportunities, and Implications for the Precision Medicine Initiative.

J Natl Compr Canc Netw. 2017 Feb;15(2):219-228. doi: 10.6004/jnccn.2017.0022. Epub 2017 Feb 10.

Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel.

Appl Transl Genom. 2016 May 25;10:19-24. doi: 10.1016/j.atg.2016.05.004. eCollection 2016 Sep.

文献AI研究员

20分钟写一篇综述，助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型，支持多种主流文档格式。

立即体验

相似文献

The FDA and genetic testing.

N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27.

The FDA and genomic tests--getting regulation right.

N Engl J Med. 2015 Jun 4;372(23):2258-64. doi: 10.1056/NEJMsr1501194. Epub 2015 May 27.

In search of a coherent framework: options for FDA oversight of genetic tests.

Food Drug Law J. 2007;62(4):617-52.

Regulating genetic tests: issues that guide policy decisions.

Genet Test Mol Biomarkers. 2012 Jan;16(1):1-2. doi: 10.1089/gtmb.2011.1527.

Policy implications of genetic testing: not just for geneticists anymore.

Adv Chronic Kidney Dis. 2006 Apr;13(2):178-82. doi: 10.1053/j.ackd.2006.01.003.

Genetic testing and FDA regulation: overregulation threatens the emergence of genomic medicine.

JAMA. 2015 Feb 17;313(7):669-70. doi: 10.1001/jama.2014.18145.

Pharmacogenetics and ethical considerations: why care?

Pharmacogenomics J. 2007 Oct;7(5):293-6. doi: 10.1038/sj.tpj.6500425. Epub 2006 Oct 10.

Standards and controls for genetic testing.

Cancer Biomark. 2005;1(4-5):217-20. doi: 10.3233/cbm-2005-14-503.

The incorporation of new technologies into genetic services; the importance of government support.

Birth Defects Orig Artic Ser. 1992;28(3):126-30.

Molecular medicine: how, what, and when?

Clin Pharmacol Ther. 2007 Oct;82(4):376-8. doi: 10.1038/sj.clpt.6100349.

引用本文的文献

The need for polygenic score reporting standards in evidence-based practice: lipid genetics use case.

Curr Opin Lipidol. 2021 Apr 1;32(2):89-95. doi: 10.1097/MOL.0000000000000733.

Payer Coverage for Hereditary Cancer Panels: Barriers, Opportunities, and Implications for the Precision Medicine Initiative.

J Natl Compr Canc Netw. 2017 Feb;15(2):219-228. doi: 10.6004/jnccn.2017.0022. Epub 2017 Feb 10.

Barriers to clinical adoption of next generation sequencing: Perspectives of a policy Delphi panel.

Appl Transl Genom. 2016 May 25;10:19-24. doi: 10.1016/j.atg.2016.05.004. eCollection 2016 Sep.