Evidence map›Paper›PMID 42495546›Full record

ReviewiScience2026

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

Tung-Hu Tsai

Abstract readReview
In one paragraph

Review in iScience, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Tung-Hu TsaiSchool of Chinese Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei 112, Taiwan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

BARDA Other Transaction Authoritydisaster preparedness lawemergency use authorizationpandemic medical countermeasuresPREP Actremdesivir

Identifiers

PMID42495546
PMCPMC13393741

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.