Evidence map›Paper›PMID 39885757›Full record

ArticleThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2024

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US.

Mirre Scholte, Liam Bendicksen, Sabine E Grimm, Teebah Abu-Zahra, Bianca Pauly, Manuela Joore, Aaron S Kesselheim

Abstract readComparative Study
In one paragraph

Article in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

7 authors.

Mirre ScholteDEPARTMENT OF CLINICAL EPIDEMIOLOGY & MEDICAL TECHNOLOGY ASSESSMENT (KEMTA), MAASTRICHT UNIVERSITY MEDICAL CENTRE, MAASTRICHT, THE NETHERLANDS.ORCID 0000-0003-3102-6011
Liam BendicksenPROGRAM ON REGULATION, THERAPEUTICS, AND LAW (PORTAL), DIVISION OF PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS, DEPARTMENT OF MEDICINE, BRIGHAM & WOMEN'S HOSPITAL/HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA.ORCID 0000-0002-0355-0716
Sabine E GrimmDEPARTMENT OF CLINICAL EPIDEMIOLOGY & MEDICAL TECHNOLOGY ASSESSMENT (KEMTA), MAASTRICHT UNIVERSITY MEDICAL CENTRE, MAASTRICHT, THE NETHERLANDS.
Teebah Abu-ZahraDEPARTMENT OF CLINICAL EPIDEMIOLOGY & MEDICAL TECHNOLOGY ASSESSMENT (KEMTA), MAASTRICHT UNIVERSITY MEDICAL CENTRE, MAASTRICHT, THE NETHERLANDS.
Bianca PaulyREGULATORY AFFAIRS DEPARTMENT, 3D-PHARMXCHANGE, TILBURG, THE NETHERLANDS.
Manuela JooreDEPARTMENT OF CLINICAL EPIDEMIOLOGY & MEDICAL TECHNOLOGY ASSESSMENT (KEMTA), MAASTRICHT UNIVERSITY MEDICAL CENTRE, MAASTRICHT, THE NETHERLANDS.
Aaron S KesselheimPROGRAM ON REGULATION, THERAPEUTICS, AND LAW (PORTAL), DIVISION OF PHARMACOEPIDEMIOLOGY AND PHARMACOECONOMICS, DEPARTMENT OF MEDICINE, BRIGHAM & WOMEN'S HOSPITAL/HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA.

Funding

European Health and Digital Executive Agency 101057619
6 · The paper itself

Abstract

To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

Indexed as

Drug ApprovalDrug RepositioningEuropean UnionUnited States Food and Drug AdministrationHumansUnited KingdomUnited StatesDrug ApprovalsDrug RepurposingEuropean Medicines AgencyPrescription Drug RegulationUK Medicines and Healthcare Products Regulatory AgencyUS Food and Drug Administration

Identifiers

PMID39885757
PMCPMC11788669

What OpenQuestion holds

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Read underepoch 390

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.