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

• Principais autores: Rick A. Vreman (Autor), Lourens T. Bloem (Autor), Stijn van Oirschot (Autor), Jarno Hoekman (Autor), Menno E. van der Elst (Autor), Hubert GM Leufkens (Autor), Olaf H. Klungel (Autor), Wim G. Goettsch (Autor), Aukje K. Mantel-Teeuwisse (Autor)
• Formato: Livro
• Publicado em: Kerman University of Medical Sciences, 2022-05-01T00:00:00Z.
• Assuntos: article
• Acesso em linha: Connect to this object online.

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...