Current regulatory approaches for accessing potential COVID-19 therapies

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Halimi, Vesa, Daci, Armond, Stojanovska, Simona, Panovska-Stavridis, Irina, Stevanovic, Milena, Filipce, Venko, Grozdanova, Aleksandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Commentary
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229878/
https://www.ncbi.nlm.nih.gov/pubmed/32454981
http://dx.doi.org/10.1186/s40545-020-00222-6
_version_ 1783534842105823232
author Halimi, Vesa
Daci, Armond
Stojanovska, Simona
Panovska-Stavridis, Irina
Stevanovic, Milena
Filipce, Venko
Grozdanova, Aleksandra
author_facet Halimi, Vesa
Daci, Armond
Stojanovska, Simona
Panovska-Stavridis, Irina
Stevanovic, Milena
Filipce, Venko
Grozdanova, Aleksandra
author_sort Halimi, Vesa
collection PubMed
description 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.
format Online
Article
Text
id pubmed-7229878
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-72298782020-05-18 Current regulatory approaches for accessing potential COVID-19 therapies Halimi, Vesa Daci, Armond Stojanovska, Simona Panovska-Stavridis, Irina Stevanovic, Milena Filipce, Venko Grozdanova, Aleksandra J Pharm Policy Pract Commentary 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. BioMed Central 2020-05-16 /pmc/articles/PMC7229878/ /pubmed/32454981 http://dx.doi.org/10.1186/s40545-020-00222-6 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Halimi, Vesa
Daci, Armond
Stojanovska, Simona
Panovska-Stavridis, Irina
Stevanovic, Milena
Filipce, Venko
Grozdanova, Aleksandra
Current regulatory approaches for accessing potential COVID-19 therapies
title Current regulatory approaches for accessing potential COVID-19 therapies
title_full Current regulatory approaches for accessing potential COVID-19 therapies
title_fullStr Current regulatory approaches for accessing potential COVID-19 therapies
title_full_unstemmed Current regulatory approaches for accessing potential COVID-19 therapies
title_short Current regulatory approaches for accessing potential COVID-19 therapies
title_sort current regulatory approaches for accessing potential covid-19 therapies
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229878/
https://www.ncbi.nlm.nih.gov/pubmed/32454981
http://dx.doi.org/10.1186/s40545-020-00222-6
work_keys_str_mv AT halimivesa currentregulatoryapproachesforaccessingpotentialcovid19therapies
AT daciarmond currentregulatoryapproachesforaccessingpotentialcovid19therapies
AT stojanovskasimona currentregulatoryapproachesforaccessingpotentialcovid19therapies
AT panovskastavridisirina currentregulatoryapproachesforaccessingpotentialcovid19therapies
AT stevanovicmilena currentregulatoryapproachesforaccessingpotentialcovid19therapies
AT filipcevenko currentregulatoryapproachesforaccessingpotentialcovid19therapies
AT grozdanovaaleksandra currentregulatoryapproachesforaccessingpotentialcovid19therapies

Ejemplares similares