Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency

Drug regulators assess and describe uncertainties regarding treatment outcomes and the benefit-risk balance of newly authorised medicines. We aimed to evaluate the type and number of uncertainties described in the benefit-risk assessment for initial marketing authorisations of oncology medicines ass...

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Veröffentlicht in:	ESMO open 2024-12, Vol.9 (12), p.103991, Article 103991
Hauptverfasser:	Taams, A.C., Herberts, C.A., Egberts, A.C.G., Zafiropoulos, N., Pignatti, F., Bloem, L.T.
Format:	Artikel
Sprache:	eng
Schlagworte:	Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use classification Drug Approval Europe European Medicines Agency European Union Humans Medical Oncology - standards Neoplasms - drug therapy oncology medicines regulatory decision making Risk Assessment uncertainties Uncertainty
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