Remdesivir from failed Ebola drug to first FDA-approved COVID-19 antiviral: The medico-legal integration.

Remdesivir became the first antiviral for COVID-19 to receive emergency use authorization (EUA) and, subsequently, full FDA approval. This article provides a statutory analysis of its development life cycle, tracing the contributions of nine US federal statutes from foundational coronavirus science through full approval, using a qualitative regulatory-science method that combines doctrinal and document analysis. Each statute is mapped onto a staged life cycle framework. The National Institute of Allergy and Infectious Diseases, under 42 U.S.C. § 282, designed and ran the pivotal the adaptive COVID-19 treatment trial (ACTT-1), generating EUA-supporting evidence in 14 weeks; Biomedical Advanced Research and Development Authority's (BARDA) Other Transaction Authority enabled at-risk manufacturing before the EUA; the Project BioShield Act addressed the market failure of an intravenous, hospital-only antiviral; and the Defense Production Act supported domestic supply. Together, these interdependent statutes show how an integrated legal architecture compressed development into months. Sustaining this institutional infrastructure is the most consequential investment in pandemic preparedness.