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The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs
Background: The European Medicines Agency (EMA) aims to resolve uncertainties associated with conditionally approved drugs by imposing post-approval studies. Results from these studies may be relevant for health technology assessment (HTA) organizations. This study investigated the role of regulator...
Autores principales: | Vreman, Rick A., Bloem, Lourens T., van Oirschot, Stijn, Hoekman, Jarno, van der Elst, Menno E., Leufkens, Hubert GM, Klungel, Olaf H., Goettsch, Wim G., Mantel-Teeuwisse, Aukje K. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Kerman University of Medical Sciences
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9309934/ https://www.ncbi.nlm.nih.gov/pubmed/33131224 http://dx.doi.org/10.34172/ijhpm.2020.198 |
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