Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma-Reference-Cited by-同舟云学术

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Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

Published:2008-09-12 Issue:10 Volume:7 Page:818-826
ISSN:1474-1776
Container-title:Nature Reviews Drug Discovery
language:en
Short-container-title:Nat Rev Drug Discov

Author:

Eichler Hans-Georg,Pignatti Francesco,Flamion Bruno,Leufkens Hubert,Breckenridge Alasdair

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Link

http://www.nature.com/articles/nrd2664.pdf

Reference52 articles.

1. Ross, D. B. The FDA and the case of Ketek. N. Engl. J. Med. 356, 1601–1604 (2007).

2. Garattini, S. & Bertele, V. How can we regulate medicines better? BMJ 335, 803–805 (2007).

3. Nissen, S. E. & Wolski, K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N. Engl. J. Med. 356, 2457–2471 (2007).

4. Carpenter, D., Zucker, E. J. & Avorn, J. Drug-review deadlines and safety problems. N. Engl. J. Med. 358, 1354–1361 (2008).

5. Barbui, C. & Garattini S. Regulatory policies on medicines for psychiatric disorders: is Europe on target? Br. J. Psychiatry 190, 91–93 (2007).

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