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

• Автори: Rick A. Vreman (Автор), Lourens T. Bloem (Автор), Stijn van Oirschot (Автор), Jarno Hoekman (Автор), Menno E. van der Elst (Автор), Hubert GM Leufkens (Автор), Olaf H. Klungel (Автор), Wim G. Goettsch (Автор), Aukje K. Mantel-Teeuwisse (Автор)
• Формат: Книга
• Опубліковано: Kerman University of Medical Sciences, 2022-05-01T00:00:00Z.
• Предмети: article
• Онлайн доступ: 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...