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A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.
Clin Pharmacol Ther. 2020 Jan;107(1):195-202. doi: 10.1002/cpt.1565. Epub 2019 Aug 14.
Clin Pharmacol Ther. 2020.
PMID: 31306483
Free PMC article.
Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations.
Hanaizi Z, Kweder S, Thor S, Ribeiro S, Marcal A.
Hanaizi Z, et al.
Ther Innov Regul Sci. 2023 Mar;57(2):321-328. doi: 10.1007/s43441-022-00475-0. Epub 2022 Oct 28.
Ther Innov Regul Sci. 2023.
PMID: 36307671
Free PMC article.
Review.
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The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.
Hanaizi Z, van Zwieten-Boot B, Calvo G, Lopez AS, van Dartel M, Camarero J, Abadie E, Pignatti F.
Hanaizi Z, et al.
Eur J Cancer. 2012 Jan;48(2):237-42. doi: 10.1016/j.ejca.2011.09.018. Epub 2011 Oct 24.
Eur J Cancer. 2012.
PMID: 22030452
Review.
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The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use.
Hanaizi Z, Flores B, Hemmings R, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.
Hanaizi Z, et al.
Oncologist. 2015 Mar;20(3):329-34. doi: 10.1634/theoncologist.2014-0073. Epub 2015 Feb 11.
Oncologist. 2015.
PMID: 25673103
Free PMC article.
Review.
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The European medicines agency review of bosutinib for the treatment of adult patients with chronic myelogenous leukemia: summary of the scientific assessment of the committee for medicinal products for human use.
Hanaizi Z, Unkrig C, Enzmann H, Camarero J, Sancho-Lopez A, Salmonson T, Gisselbrecht C, Laane E, Pignatti F.
Hanaizi Z, et al.
Oncologist. 2014 Apr;19(4):421-5. doi: 10.1634/theoncologist.2013-0294. Epub 2014 Mar 25.
Oncologist. 2014.
PMID: 24668331
Free PMC article.
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