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本文引用的文献

1
New FDA guidance on off-label promotion falls short for everyone: obama administration is likely to revisit it.美国食品药品监督管理局（FDA）关于药品未标示用途推广的新指南对各方都有所欠缺：奥巴马政府可能会重新审视该指南。
P T. 2009 Mar;34(3):122-3.
2
Shifting terrain in the regulation of off-label promotion of pharmaceuticals.药品未标示用途推广监管方面不断变化的形势。
N Engl J Med. 2009 Apr 9;360(15):1557-66. doi: 10.1056/NEJMhle0807695.
3
Informed consent and shared decision-making: a requirement to disclose to patients off-label prescriptions.知情同意与共同决策：向患者披露药品未标示用途处方的要求。
PLoS Med. 2008 Nov 11;5(11):e223. doi: 10.1371/journal.pmed.0050223.
4
Off-label promotion, on-target sales.未标靶推广，目标明确销售。
PLoS Med. 2008 Oct 28;5(10):e210. doi: 10.1371/journal.pmed.0050210.
5
ASHP guidelines on the pharmacy and therapeutics committee and the formulary system.美国卫生系统药师协会关于药事与治疗学委员会及药品目录系统的指南。
Am J Health Syst Pharm. 2008 Jul 1;65(13):1272-83. doi: 10.2146/ajhp080086.
6
FDA guidance on off-label promotion and the state of the literature from sponsors.美国食品药品监督管理局关于药品未标示用途推广的指南及申办方的文献状况。
JAMA. 2008 Apr 23;299(16):1949-51. doi: 10.1001/jama.299.16.1949.
7
Experts weigh in on promotion, prescription of off-label drugs.专家就非标签药物的推广及处方发表意见。
JAMA. 2007 Feb 21;297(7):683-4. doi: 10.1001/jama.297.7.683.
8
Off-label or out of bounds? Prescriber and marketer liability for unapproved uses of FDA-approved drugs.未标示用途还是越界行为？开处方者和营销商对FDA批准药物的未批准用途所承担的责任。
Ann Health Law. 2003 Summer;12(2):295-324, table of contents.
9
The role of marketing in pharmaceutical research and development.营销在药物研发中的作用。
Pharmacoeconomics. 2002;20 Suppl 3:77-85. doi: 10.2165/00019053-200220003-00008.

Off-label drug information: regulation, distribution, evaluation, and related controversies.

作者信息

Ventola C Lee

出版信息

P T. 2009 Aug;34(8):428-40.

PMID:20140107
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2799128/
Abstract
摘要