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 Milena Stevanovikj 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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s40545-020-00222-6.pdf | 488.99 kB | Adobe PDF | View/Open |
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