Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease

Alignment of European Regulatory and Health Technology Assessments: A Review of Licensed Products for Alzheimer's Disease

Aims: To facilitate regulatory learning, we evaluated similarities and differences in evidence requirements between regulatory and health technology assessment (HTA) bodies of Alzheimer's disease (AD) approved products.Methods: The European marketing authorisation application dossiers and Europ...

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Bibliographic Details
Main Authors: Marieke J. H. J. Dekker, Jacoline C. Bouvy, Diana O'Rourke, Robin Thompson, Amr Makady, Pall Jonsson, Christine C. Gispen-de Wied
Format: Article
Language:English
Published: Frontiers Media S.A. 2019-05-01
Series:Frontiers in Medicine
Subjects:
health technology assessments
regulatory assessments
alignment
Alzheimer's disease
regulatory science
Online Access:https://www.frontiersin.org/article/10.3389/fmed.2019.00073/full

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