Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin-Reference-Cited by-同舟云学术

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Differences in drug approval processes of 3 regulatory agencies: a case study of gemtuzumab ozogamicin

Published:2012-09-11 Issue:2 Volume:31 Page:473-478
ISSN:0167-6997
Container-title:Investigational New Drugs
language:en
Short-container-title:Invest New Drugs

Author:

Tanimoto Tetsuya,Tsubokura Masaharu,Mori Jinichi,Pietrek Monika,Ono Shunsuke,Kami Masahiro

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Oncology

Link

http://link.springer.com/content/pdf/10.1007/s10637-012-9877-8.pdf

Reference33 articles.

1. Goozner M (2010) FDA increases focus on postmarketing studies. J Natl Cancer Inst 102(17):1302–1304

2. Young RC (2010) Cancer clinical trials—a chronic but curable crisis. N Engl J Med 363(4):306–309

3. Richey EA, Lyons EA, Nebeker JR et al (2009) Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs? J Clin Oncol 27(26):4398–4405

4. Boon WP, Moors EH, Meijer A, Schellekens H (2010) Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe. Clin Pharmacol Ther 88(6):848–853

5. Shibuya K, Hashimoto H, Ikegami N et al (2011) Future of Japan’s system of good health at low cost with equity: beyond universal coverage. Lancet 378(9798):1265–1273

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