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Title: Pharmacogenomics information in official drug labelling
Authors: Azzopardi, Yasmine
Wirth, Francesca
Camilleri, Liberato
Serracino-Inglott, Anthony
Azzopardi, Lilian M.
Keywords: Pharmacogenomics -- Research
Drugs -- Labeling
United States. Food and Drug Administration
European Agency for the Evaluation of Medicinal Products
Issue Date: 2019-09
Publisher: University of Malta. Department of Pharmacy
Citation: Azzopardi, Y., Wirth, F., Camilleri, L., Serracino-Inglott, A., & Azzopardi, L. M. (2019, September). Pharmacogenomics information in official drug labelling. Poster session presented at the 79th FIP World Congress of Pharmacy and Pharmaceutical Sciences 2019, Abu Dhabi, United Arab Emirates.
Abstract: A poster presentation regarding pharmacogenomics information in official drug labelling. Introduction: The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are continually updating drug labels and Summary of Product Characteristic s (SmPC) with pharmacogenomic (PGx) information. Harmonisation of PGx information in drug labelling between regulatory bodies facilitates clinical implementation of PGx. Aims: ● To compare PGx information in official drug labelling between the US FDA and the EMA: Inclusion of PGx information within headings and sub-headings of drug labels and SmPCs ● Quality of PGx information in drug labels and SmPCs.
Appears in Collections:Scholarly Works - FacM&SPha

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