Current regulatory approaches for accessing potential COVID-19 therapies

Vesa Halimi; Armond Daci; Simona Stojanovska; Irina Panovska-Stavridis; Milena Stevanovikj; Venko Filipce; Grozdanova, Aleksandra

doi:https://doi.org/10.1186/s40545-020-00222-6

Current regulatory approaches for accessing potential COVID-19 therapies

Journal

Journal of Pharmaceutical Policy and Practice

Date Issued

2020-05-16

Author(s)

Vesa Halimi

Armond Daci

Simona Stojanovska

DOI

https://doi.org/10.1186/s40545-020-00222-6

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.

Subjects

COVID-19

regulatory EMA

FDA

clinical studies

compassionate use

clinical practice

off-label use

emergency use

File(s)

Name

s40545-020-00222-6.pdf

Size

488.99 KB

Format

Adobe PDF

Checksum

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