Frontiers in Medicine | Regulatory Science

Opinion

Published on 01 Aug 2024

Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs

in Regulatory Science

Laura Vierbaum
Patricia Kaiser
Michael Spannagl
Folker Wenzel
Mario Thevis
Ingo Schellenberg

Frontiers in Medicine

doi 10.3389/fmed.2024.1416642

2,260 views
2 citations

Original Research

Published on 31 Jul 2024

More than red tape: exploring complexity in medical device regulatory affairs

in Regulatory Science

Yu Han
Aaron Ceross
Jeroen Bergmann

Frontiers in Medicine

doi 10.3389/fmed.2024.1415319

8,619 views
7 citations

Original Research

Published on 31 Jul 2024

Shared decision-making implementation status among dermatologists engaging in medical esthetics: a cross-sectional study in China

in Regulatory Science

Shiyuan Li
Jing Fan
Yan Qiang
Zhen Duan
Ruiping Wang

Frontiers in Medicine

doi 10.3389/fmed.2024.1418917

2,012 views
1 citation

Original Research

Published on 30 Jul 2024

A scalable and transparent data pipeline for AI-enabled health data ecosystems

in Regulatory Science

Tuncay Namli
Ali Anıl Sınacı
Suat Gönül
Cristina Ruiz Herguido
Patricia Garcia-Canadilla
Adriana Modrego Muñoz
Arnau Valls Esteve
Gökçe Banu Laleci Ertürkmen

Frontiers in Medicine

doi 10.3389/fmed.2024.1393123

5,025 views
16 citations

Perspective

Published on 29 Jul 2024

Drug repurposing in Rett and Rett-like syndromes: a promising yet underrated opportunity?

in Regulatory Science

Claudia Fuchs
Peter A. C. ‘t Hoen
Annelieke R. Müller
Friederike Ehrhart
Clara D. M. Van Karnebeek

Frontiers in Medicine

doi 10.3389/fmed.2024.1425038

4,763 views
2 citations

Systematic Review

Published on 18 Jul 2024

The impact of global falsified medicines regulation on healthcare stakeholders in the legitimate pharmaceutical supply chain: a systematic review

in Regulatory Science

Ellen Melia
Aislinn English
Bernard D. Naughton

Frontiers in Medicine

doi 10.3389/fmed.2024.1429872

6,212 views
5 citations

Perspective

Published on 17 Jul 2024

Integrity at stake: confronting “publish or perish” in the developing world and emerging economies

in Regulatory Science

Jorge Vasconez-Gonzalez
Juan S. Izquierdo-Condoy
Patricio Naranjo-Lara
Miguel Ángel Garcia-Bereguiain
Esteban Ortiz-Prado

Frontiers in Medicine

doi 10.3389/fmed.2024.1405424

9,665 views
17 citations

Original Research

Published on 17 Jul 2024

Assessing the credibility of a drug’s effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

in Regulatory Science

Joyce M. Hoek
Jonna Brenninkmeijer
Ymkje Anna de Vries
Rob R. Meijer
Don van Ravenzwaaij

Frontiers in Medicine

doi 10.3389/fmed.2024.1409259

2,171 views
1 citation

Policy Brief

Published on 17 Jul 2024

Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants

in Regulatory Science

Ciara Staunton
Johanna M. C. Blom
Deborah Mascalzoni
on behalf of the IMI FACILITATE Consortium

Frontiers in Medicine

doi 10.3389/fmed.2024.1408600

2,814 views
2 citations

Original Research

Published on 16 Jul 2024

A reference architecture for personal health data spaces using decentralized content-addressable storage networks

in Regulatory Science

Toomas Klementi
Gunnar Piho
Peeter Ross

Frontiers in Medicine

doi 10.3389/fmed.2024.1411013

5,175 views
8 citations

Review

Published on 10 Jul 2024

A comprehensive analysis of digital health-focused Living Labs: innovative approaches to dementia

in Regulatory Science

Teodora Figueiredo
Luís Midão
Joana Carrilho
Diogo Videira Henriques
Sara Alves
Natália Duarte
Maria João Bessa
José María Fidalgo
Maria García
David Facal

Frontiers in Medicine

doi 10.3389/fmed.2024.1418612

3,812 views
5 citations

Original Research

Published on 05 Jul 2024

Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register

in Regulatory Science

Anwesha Dhal Samanta
Rishima Borah
Gayatri Saberwal

Frontiers in Medicine

doi 10.3389/fmed.2024.1357930

1,844 views
1 citation

Opinion

Published on 03 Jul 2024

Enhancing the quality and efficiency of regulatory science literature reviews through innovation and collaboration with library and information science experts

in Regulatory Science

Elizabeth R. Stevens
Gregory Laynor

Frontiers in Medicine

doi 10.3389/fmed.2024.1434427

2,798 views
3 citations

Original Research

Published on 03 Jul 2024

One hundred years of Ecuadorian biomedical scientific output and its association with the main causes of mortality: a bibliometric study

in Regulatory Science

Ivan Sisa
Jhon Caicedo-Potosí
María Cordovez
Clara Verdezoto
Mishell Barreno
Martín Coral
Gricelda Herrera-Franco

Frontiers in Medicine

doi 10.3389/fmed.2024.1395433

5,796 views
5 citations

Original Research

Published on 01 Jul 2024

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

in Regulatory Science

Yong Yang
Rui Jiang
Gengliang Bai
Qingqing Liu
Yongfa Chen

Frontiers in Medicine

doi 10.3389/fmed.2024.1409270

2,268 views
1 citation

Original Research

Published on 27 Jun 2024

Showcasing the Saudi e-referral system experience: the epidemiology and pattern of referrals utilising nationwide secondary data

in Regulatory Science

Nawfal A. Aljerian
Abdullah A. Alharbi
Reem S. AlOmar
Meshary S. Binhotan
Hani A. Alghamdi
Mohammed S. Arafat
Abdulrahman Aldhabib
Mohammed K. Alabdulaali

Frontiers in Medicine

doi 10.3389/fmed.2024.1348442

5,714 views
10 citations

Policy Brief

Published on 24 Jun 2024

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

in Regulatory Science

Mariia V. Maksimova
Ghislaine J. M. W. van Thiel
Yke Tromp
Rosan Lechner
Johannes J. M. van Delden
Lourens T. Bloem

Frontiers in Medicine

doi 10.3389/fmed.2024.1408553

3,273 views
5 citations

Systematic Review

Published on 21 Jun 2024

Systematic review on the implementation of metrological assurance systems for medical devices in Latin America

in Regulatory Science

Harold M. Farfán-Vargas
Dante Espinoza-Morriberon
Marcia M. Moya-Salazar
Hans Contreras-Pulache
Jeel Moya-Salazar

Frontiers in Medicine

doi 10.3389/fmed.2024.1281199

6,291 views

Original Research

Published on 17 Jun 2024

Lessons learned: avoiding bias via multi-state analysis of patients’ trajectories in real-time

in Regulatory Science

Elisabeth Lucke
Derek Hazard
Marlon Grodd
Susanne Weber
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1390549

2,521 views

Original Research

Published on 17 Jun 2024

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration

in Regulatory Science

John Owen
Anando Sen
Beate Aurich
Corinna Engel
Giacomo Cavallaro
Eva Degraeuwe
Dipak Kalra
Ronald Cornet
Melissa Walsh
Teresa Berkery

Frontiers in Medicine

doi 10.3389/fmed.2024.1370916

4,316 views
5 citations

Original Research

Published on 12 Jun 2024

Protection from prior natural infection vs. vaccination against SARS-CoV-2—a statistical note to avoid biased interpretation

in Regulatory Science

Susanne Weber
Pontus Hedberg
Pontus Naucler
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1376275

1,948 views

Mini Review

Published on 10 Jun 2024

New clinical insight in amyotrophic lateral sclerosis and innovative clinical development from the non-profit repurposing trial of the old drug guanabenz

in Regulatory Science

Anna Ambrosini
Eleonora Dalla Bella
Maddalena Ravasi
Mario Melazzini
Giuseppe Lauria

Frontiers in Medicine

doi 10.3389/fmed.2024.1407912

2,666 views

Brief Research Report

Published on 05 Jun 2024

Clinical development and marketing application review times for novel orphan-designated drugs

in Regulatory Science

Ebru Demirci
Jennifer Knicley
Lori Fiorentino

Frontiers in Medicine

doi 10.3389/fmed.2024.1404922

3,457 views
4 citations

Original Research

Published on 05 Jun 2024

Streamlining intersectoral provision of real-world health data: a service platform for improved clinical research and patient care

in Regulatory Science

Katja Hoffmann
Igor Nesterow
Yuan Peng
Elisa Henke
Daniela Barnett
Cigdem Klengel
Mirko Gruhl
Martin Bartos
Frank Nüßler
Richard Gebler

Frontiers in Medicine

doi 10.3389/fmed.2024.1377209

3,725 views
6 citations

518 articles

articles

Experiences and challenges for EQA providers in assessing the commutability of control materials in accuracy-based EQA programs

More than red tape: exploring complexity in medical device regulatory affairs

Shared decision-making implementation status among dermatologists engaging in medical esthetics: a cross-sectional study in China

A scalable and transparent data pipeline for AI-enabled health data ecosystems

Drug repurposing in Rett and Rett-like syndromes: a promising yet underrated opportunity?

The impact of global falsified medicines regulation on healthcare stakeholders in the legitimate pharmaceutical supply chain: a systematic review

Integrity at stake: confronting “publish or perish” in the developing world and emerging economies

Assessing the credibility of a drug’s effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants

A reference architecture for personal health data spaces using decentralized content-addressable storage networks

A comprehensive analysis of digital health-focused Living Labs: innovative approaches to dementia

Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register

Enhancing the quality and efficiency of regulatory science literature reviews through innovation and collaboration with library and information science experts

One hundred years of Ecuadorian biomedical scientific output and its association with the main causes of mortality: a bibliometric study

Discussion of the classification of pediatric drug clinical trials in children's hospitals in China

Showcasing the Saudi e-referral system experience: the epidemiology and pattern of referrals utilising nationwide secondary data

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

Systematic review on the implementation of metrological assurance systems for medical devices in Latin America

Lessons learned: avoiding bias via multi-state analysis of patients’ trajectories in real-time

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration

Protection from prior natural infection vs. vaccination against SARS-CoV-2—a statistical note to avoid biased interpretation

New clinical insight in amyotrophic lateral sclerosis and innovative clinical development from the non-profit repurposing trial of the old drug guanabenz

Clinical development and marketing application review times for novel orphan-designated drugs

Streamlining intersectoral provision of real-world health data: a service platform for improved clinical research and patient care