Approval probabilities and regulatory review patterns for anticancer drugs in the European Union

Abstract Aim This article reviews outcomes of marketing authorization applications for anticancer drugs in the EU and outlines factors and hurdles of impact. Methods Procedures for initial approval of anticancer and non-cancer drugs were analyzed and compared to anticancer drug approvals in the USA...

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Veröffentlicht in:	Critical reviews in oncology/hematology 2013-08, Vol.87 (2), p.112-121
Hauptverfasser:	Hartmann, Markus, Mayer-Nicolai, Christine, Pfaff, Otmar
Format:	Artikel
Sprache:	eng
Schlagworte:	Anticancer drug approval Antineoplastic Agents Approval probability Drug approval Drug Approval - legislation & jurisprudence Drug Approval - methods Drug evaluation European Medicines Agency European Union Hematology, Oncology and Palliative Medicine Humans Marketing authorization application Neoplasms Regulatory review pattern
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