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Title: A comparison of approved indications between regulatory agencies
Authors: Camilleri, Matthew
Borg, John-Joseph
Sammut Bartolo, Nicolette
Serracino-Inglott, Anthony
Keywords: Drug evaluation -- Standards
Administrative agencies -- Medical care
European Agency for the Evaluation of Medicinal Products
Drugs -- Law and legislation -- United States
Drugs -- Law and legislation -- Europe
Cardiovascular agents
Issue Date: 2018-10
Publisher: University of Malta. Department of Pharmacy
Citation: Camilleri, M., Borg, J. J., Sammut Bartolo, N., & Serracino-Inglott, A. (2018, October). A comparison of approved indications between regulatory agencies. Poster session presented at the ACCP Global Conference on Clinical Pharmacy, Seattle, Washington, USA.
Abstract: A poster presentation regarding a comparison of approved indications between regulatory agencies. Introduction: Medicinal products are allowed on the market following approval by autonomous regulatory agencies which are tasked with their evaluation. Differences in evaluation practices during the registration of medicinal products are found in Europe and the United States of America which may lead to discrepancies in clinical guidelines, pricing policies, and drug use. Aims: To compare the differences in the indications of medicinal products authorised by the European Medicines Agency (EMA) and the US Food & Drug Administration using new molecular entity cardiology-related medicinal products as examples.
Appears in Collections:Scholarly Works - FacM&SPha

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