Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice.
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Off-label use of targeted therapies in oncologyMoving molecular targeted drug therapy towards personalized medicine: issues related to clinical trial designFast-track drug approval in inflammatory bowel diseasesOncology drug development and approval of systemic anticancer therapy by the U.S. Food and Drug AdministrationRegulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.Off-label use of anti-cancer drugs between clinical practice and research: the Italian experience.Panitumumab in metastatic colorectal cancer.Panitumumab in the management of patients with KRAS wild-type metastatic colorectal cancer.Current treatment landscape for relapsed and/or refractory multiple myeloma.Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?Nanomedicine and cancer immunotherapy - targeting immunosuppressive cells.Tumor-associated macrophages and anti-tumor therapies: complex links.Clinical trial designs to obtain marketing authorization of drugs for haematological malignancy in Japan, the EU and the US.Cross-comparison of cancer drug approvals at three international regulatory agencies.Toward a jurisprudence of drug regulation.Use of the conditional marketing authorization pathway for oncology medicines in Europe.Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs.When everyone is an orphan: against adopting a U.S.-styled orphan drug policy in Canada.In response to Alqahtani et al. (2015 Jul; 24(7):709-15): suggesting an international regulatory harmonization for priority review drugs need further investigations.
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P2860
Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice.
description
article científic
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article scientifique
@fr
articolo scientifico
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artigo científico
@pt
bilimsel makale
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scientific article published on 02 May 2011
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vedecký článok
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vetenskaplig artikel
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videnskabelig artikel
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vědecký článek
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name
Evaluation of oncology drugs a ...... n impact on clinical practice.
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Evaluation of oncology drugs a ...... n impact on clinical practice.
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type
label
Evaluation of oncology drugs a ...... n impact on clinical practice.
@en
Evaluation of oncology drugs a ...... n impact on clinical practice.
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prefLabel
Evaluation of oncology drugs a ...... n impact on clinical practice.
@en
Evaluation of oncology drugs a ...... n impact on clinical practice.
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P2093
P356
P1476
Evaluation of oncology drugs a ...... n impact on clinical practice.
@en
P2093
Francesco Trotta
Giovanni Tafuri
Hubert G M Leufkens
Jan H M Schellens
Richard Laing
P304
P356
10.1200/JCO.2010.34.1248
P407
P577
2011-05-02T00:00:00Z