Current regulatory approaches for accessing potential COVID-19 therapies

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.

Metal Complexes and Their Potential Therapeutic Role Against COVID-19: Recent Developments in Drug Designing

“…These vaccines provide a prophylactic defense to healthy people but may be less useful in the emergence of virus variants and patients with a compromised immune system. Therefore, it is necessary to seek additional novel cures for COVID-19 [5].…”

Expanded Access Programs, compassionate drug use, and Emergency Use Authorizations during the COVID-19 pandemic.

“…This creates political, social, and medical urgency for governments and regulatory agencies to optimize and implement these programs [15]. Moreover, in the USA, the FDA cannot require the manufacturer to offer patients access to investigational drugs [16]. The manufacturer might not be able to give access to their investigational drug for various regulatory reasons.…”

COVID-19 e os desafios para a regulação de medicamentos em tempos de pandemia

“…Um dos desafios diz respeito às dificuldades de seguir as diretrizes para a Autorização de Uso Emergencial, tais como a aplicação do Termo de Consentimento Informado, a aprovação por Comitê de Ética Nacional e a geração de informação com o uso da tecnologia 61,62 .…”