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...

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Detalles Bibliográficos
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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Kerman University of Medical Sciences 2020
Materias:
Original Article
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

Internet

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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