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Shifting terrain in the regulation of off-label promotion of pharmaceuticals.

作者信息

Mello Michelle M, Studdert David M, Brennan Troyen A

机构信息

Department of Health Policy and Management, Harvard School of Public Health, Boston, USA.

出版信息

N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695.

DOI:10.1056/NEJMhle0807695

PMID:19357413

Abstract

摘要

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Shifting terrain in the regulation of off-label promotion of pharmaceuticals.

作者信息

Mello Michelle M, Studdert David M, Brennan Troyen A

机构信息

Department of Health Policy and Management, Harvard School of Public Health, Boston, USA.

出版信息

N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695.

DOI:10.1056/NEJMhle0807695

PMID:19357413

Abstract

摘要

相似文献

Shifting terrain in the regulation of off-label promotion of pharmaceuticals.

N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695.

Teaching clinicians about drugs--50 years later, whose job is it?

N Engl J Med. 2011 Mar 31;364(13):1185-7. doi: 10.1056/NEJMp1011713.

Marketing off-label uses to physicians: FDA's draft (mis)guidance.

Am J Bioeth. 2008 Mar;8(3):1-3. doi: 10.1080/15265160802116624.

Vioxx's history and the need for better procedures and better testing.

Seton Hall Law Rev. 2007;37(4):941-68.

Pros and cons of off-label promotion investigations and prosecutions.

Food Drug Law J. 2006;61(3):577-83.

Off-label or off-limits?

Nat Biotechnol. 2008 Aug;26(8):867-75. doi: 10.1038/nbt0808-867.

The FDA and deference lost: a self-inflicted wound or the product of a wounded agency? A response to Professor O'Reilly.

Cornell Law Rev. 2008 Jul;93(5):981-1002.

Pharmacometrics at FDA: evolution and impact on decisions.

Clin Pharmacol Ther. 2007 Jul;82(1):97-102. doi: 10.1038/sj.clpt.6100234. Epub 2007 May 30.

The challenges of globalization in pharmaceutical law--is an international drug approval system modeled after the European system worth considering?

Food Drug Law J. 2008;63(3):623-45.

Access before approval--a right to take experimental drugs?

N Engl J Med. 2006 Aug 3;355(5):437-40. doi: 10.1056/NEJMp068132.

引用本文的文献

Recommendations for Off-Label Drug Use in Ophthalmology in China: A Clinical Practice Guideline.

Front Pharmacol. 2022 May 24;13:919688. doi: 10.3389/fphar.2022.919688. eCollection 2022.

Combatting Antibiotic Resistance Together: How Can We Enlist the Help of Industry?

Antibiotics (Basel). 2018 Dec 18;7(4):111. doi: 10.3390/antibiotics7040111.

Cannabis regulatory science: risk-benefit considerations for mental disorders.

Int Rev Psychiatry. 2018 Jun;30(3):183-202. doi: 10.1080/09540261.2018.1454406. Epub 2018 May 29.

Unhealthy marketing of pharmaceutical products: An international public health concern.

J Public Health Policy. 2016 May;37(2):149-59. doi: 10.1057/jphp.2016.6. Epub 2016 Feb 25.

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.

PLoS Med. 2016 Jan 26;13(1):e1001945. doi: 10.1371/journal.pmed.1001945. eCollection 2016 Jan.

Regulating off-label drug use in India: The arena for concern.

Perspect Clin Res. 2015 Jul-Sep;6(3):129-33. doi: 10.4103/2229-3485.159935.

Off-label, but on-target: use of regadenoson with exercise.

J Nucl Cardiol. 2013 Apr;20(2):179-81. doi: 10.1007/s12350-012-9643-5.

Implementation of a publication strategy in the context of reporting biases. A case study based on new documents from Neurontin litigation.

Trials. 2012 Aug 13;13:136. doi: 10.1186/1745-6215-13-136.

Ten common questions (and their answers) about off-label drug use.

Mayo Clin Proc. 2012 Oct;87(10):982-90. doi: 10.1016/j.mayocp.2012.04.017. Epub 2012 Aug 6.

[Off-label therapy: current problems from the perspective of the Pharmaceutical Commission of the German Medical Profession].

Z Rheumatol. 2012 Feb;71(2):108-10, 112-8. doi: 10.1007/s00393-011-0901-8.