Critical review of ‘Public domain application’: a flexible drug approval system in Japan

Author:

Ito Y.,Narimatsu H.,Fukui T.,Fukao A.,Yoshioka T.

Publisher

Elsevier BV

Subject

Oncology,Hematology

Reference17 articles.

1. New sources of drugs for hematologic malignancies;Sukhai;Blood,2011

2. Review process of anticancer drugs in Japan;Hori;The Japanese Journal of Clinical Hematology,2006

3. Hurry up and wait: is accelerated approval of new cancer drugs in the best interests of cancer patients?;Schilsky;J Clin Oncol,2003

4. European Medicines Agency: Assessment report of tepadina from European Medicines Agencyhttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Public_assessment_report/human/001046/WC500090255.pdf (11 October 2012, date last accessed)

5. Critical review of the determination process by the Japanese Reviewing Authority in approving the additional efficacy of fludarabine phosphate;Narimatsu;J Clin Oncol,2009

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