Please use this identifier to cite or link to this item: http://hdl.handle.net/20.500.12188/10825
Title: Current regulatory approaches for accessing potential COVID-19 therapies
Authors: Vesa Halimi
Armond Daci
Simona Stojanovska
Irina Panovska-Stavridis 
Stevanovikj, Milena 
Venko Filipce 
Grozdanova, Aleksandra 
Keywords: COVID-19
regulatory EMA
FDA
clinical studies
compassionate use
clinical practice
off-label use
emergency use
Issue Date: 16-May-2020
Publisher: BMC Part of Springer Nature
Source: Halimi, V., Daci, A., Stojanovska, S. et al. Current regulatory approaches for accessing potential COVID-19 therapies. J Pharm Policy Pract 13, 16 (2020). https://doi.org/10.1186/s40545-020-00222-6
Journal: Journal of Pharmaceutical Policy and Practice
Abstract: This commentary aims to elaborate challenges in the regulatory approaches for accessing and investigating COVID-19 potential therapies either with off-label use, compassionate use, emergency use or for clinical trials. Since no therapies have been formally approved and completely effective and safe to date, the best clinical choice is acquired only after consistent and fair communication and collaboration between licensed clinicians, researchers, regulatory authorities, manufacturers and patients.
URI: http://hdl.handle.net/20.500.12188/10825
DOI: https://doi.org/10.1186/s40545-020-00222-6
Appears in Collections:Faculty of Medicine: Journal Articles

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