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

ABSTRACT: The US Food and Drug Administration (FDA) Expanded Access (EA) Program, which allows for compassionate uses of unapproved therapeutics and diagnostics outside of clinical trials, has gained significant traction during the Coronavirus 2019 (COVID-19) pandemic. While development of vaccines has been the major focus, uncertainties around new vaccine safety and effectiveness have spawned interest in other pharmacological options. Experimental drugs can also be approved under the FDA Emergency Use Authorization (EUA) program, designed to combat infectious disease and other threats. Here, we review the US experience in 2020 with pharmacological EA and EUA approvals during the pandemic. We also provide a description of, and clinical rationale for, each of the EA- or EUA-approved drugs (e.g. remde

SUBMITTER: Rizk JG 

PROVIDER: S-EPMC7694556 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature