Subject: COVID-19
Subject: regulatory EMA
Subject: FDA
Subject: clinical studies
Subject: compassionate use
Subject: clinical practice
Subject: off-label use
Subject: emergency use
Year: 2020
Type: Article
Title: Current regulatory approaches for accessing potential COVID-19 therapies
Author: Vesa Halimi
Author: Armond Daci
Author: Simona Stojanovska
Author: Irina Panovska-Stavridis
Author: Stevanovikj, Milena
Author: Venko Filipce
Author: Grozdanova, Aleksandra
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.
Publisher: BMC Part of Springer Nature
Relation: Journal of Pharmaceutical Policy and Practice
Identifier: oai:repository.ukim.mk:20.500.12188/10825
Identifier: 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/s40545-020-00222-6Identifier: http://hdl.handle.net/20.500.12188/10825Identifier: https://doi.org/10.1186/s40545-020-00222-6
