The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs

The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs

BackgroundThe 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-i...

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Bibliographic Details
Main Authors: Rick A. Vreman, Lourens T. Bloem, Stijn van Oirschot, Jarno Hoekman, Menno E. van der Elst, Hubert GM Leufkens, Olaf H. Klungel, Wim G. Goettsch, Aukje K. Mantel-Teeuwisse
Format: Article
Language:English
Published: Kerman University of Medical Sciences 2022-05-01
Series:International Journal of Health Policy and Management
Subjects:
conditional
authorization
health technology assessment
post-approval
relative effectiveness
evidence
Online Access:https://www.ijhpm.com/article_3939_5237014b5da5bd1d788b68c53f91716a.pdf

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