Current regulatory approaches for accessing potential COVID-19 therapies

[摘要] 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.

[学科分类] 药理学

[关键词] COVID-19;Regulatory;EMA;FDA;Clinical studies;Compassionate use;Clinical practice;Off-label use;Emergency use