Frontiers in Medicine | Regulatory Science

Hypothesis and Theory

Published on 08 Dec 2025

The challenges of national health data ecosystems in feeding the European health data space: the Italian example

in Regulatory Science

Ylenia Murgia
Roberta Gazzarata
Mario Ciampi
Mario Sicuranza
Franco Cirillo
Christian Esposito
Norbert Maggi
Gabriella Balestra
Lucia Sacchi
Mauro Giacomini

Frontiers in Medicine

doi 10.3389/fmed.2025.1644719

968 views

Original Research

Published on 04 Dec 2025

Blockchain-enabled quality by design system for clinical trials

in Regulatory Science

Reza Vatankhah Barenji
Reza Ebrahimi Hariry

Frontiers in Medicine

doi 10.3389/fmed.2025.1546897

1,673 views

Original Research

Published on 03 Dec 2025

The development of the neurosurgery workforce in Austria over the past quarter century: is more always better?

in Regulatory Science

Mario Mischkulnig
Roland Polacsek-Ernst
Lisa I. Körner
Josa Frischer
Cornelia M. Diendorfer
Christian Matula
Karl Roessler
Georg Widhalm
Christian Dorfer

Frontiers in Medicine

doi 10.3389/fmed.2025.1711856

1,065 views

Original Research

Published on 01 Dec 2025

Post-marketing surveillance of upadacitinib: multilevel analysis of venous thromboembolism reporting in global data and rheumatoid arthritis

in Regulatory Science

Renato Ferreira-da-Silva
Mariana Lobo
Ana Rafaela Abreu
Juliana Pereira-Macedo
Beatriz Mós
Carolina Ameijeiras Rodriguez
Inês Mariana Lourenço
Isabel Vieira
Jorge Junqueira Polónia
Luís Gouveia

Frontiers in Medicine

doi 10.3389/fmed.2025.1683751

2,010 views
1 citation

Original Research

Published on 26 Nov 2025

Awareness and practices of community pharmacists toward dextromethorphan misuse in Jeddah, Saudi Arabia: implications for regulation and public health

in Regulatory Science

Aisha T. Alnami
Anfal S. Aljahdali
Haifa M. Alqahtani
Maha M. Khayat
Amal J. Aloshayni
Manal M. Aleesi
Mohammed M. Aldurdunji

Frontiers in Medicine

doi 10.3389/fmed.2025.1693207

1,551 views

Review

Published on 24 Nov 2025

Nonclinical regulatory considerations for investigational new drug applications for regulatory T cell therapies

in Regulatory Science

Phuong-Uyen Dinh
Lauren Mihalcik

Frontiers in Medicine

doi 10.3389/fmed.2025.1626067

1,727 views

Original Research

Published on 21 Nov 2025

Influence of a multidirectional overground body weight support system on walking-related tasks in typically developing children and adolescents

in Regulatory Science

Hubertus J. A. van Hedel
Sophia Rhiel
Emanuel Frei-Zuercher
Urs Keller

Frontiers in Medicine

doi 10.3389/fmed.2025.1690286

912 views

Policy and Practice Reviews

Published on 20 Nov 2025

A comparison of the labeling of antineoplastic and supportive medicines in China, Japan, and the US based on the WHO essential medicines list

in Regulatory Science

Chenyu Du
Jiaxin Liu
Caiyi Wang
Pengcheng Liu

Frontiers in Medicine

doi 10.3389/fmed.2025.1600207

846 views

Review

Published on 19 Nov 2025

The status quo of the development of decentralized clinical trials

in Regulatory Science

Xiaoliang Chen
Mingxuan Zhao
Na Lei
Lichun Dong
Qiang Lv
Jiashi Sun
Jianchang He
Xianglin Zhang

Frontiers in Medicine

doi 10.3389/fmed.2025.1664648

2,261 views

Systematic Review

Published on 11 Nov 2025

The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence

in Regulatory Science

Aisha Al Azawei
Kate Loughrey
Kim Surim
Mary Elizabeth Connolly
Bernard D. Naughton

Frontiers in Medicine

doi 10.3389/fmed.2025.1687864

3,668 views

Original Research

Published on 11 Nov 2025

Assessment of compliance with good review practices by medicine assessors within the Zambia medicines regulatory authority

in Regulatory Science

Constance Sakala Chisha
Stephanie Leigh
Makomani Siyanga
Neil McAuslane
Stuart Walker

Frontiers in Medicine

doi 10.3389/fmed.2025.1706139

931 views

Original Research

Published on 11 Nov 2025

Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System

in Regulatory Science

Ayesha Yasmeen
Mamoon H. Syed
Amani Khardali
Hadi A. Almansour
Thamir M. Alshammari

Frontiers in Medicine

doi 10.3389/fmed.2025.1674331

2,226 views

Perspective

Published on 05 Nov 2025

Herbal medicines adulteration with erectile dysfunction pharmaceuticals in sub-Saharan Africa: call to strengthen regulatory measures

in Regulatory Science

Kampadilemba Ouoba
Daniel Dori
Adela Ashie
Issiaka Soulama
Rasmané Semdé

Frontiers in Medicine

doi 10.3389/fmed.2025.1694833

2,004 views

Original Research

Published on 31 Oct 2025

Reducing misdiagnosis in AI-driven medical diagnostics: a multidimensional framework for technical, ethical, and policy solutions

in Regulatory Science

Yue Li
Xin Yi
Jia Fu
Yujing Yang
ChuJie Duan
Jun Wang

Frontiers in Medicine

doi 10.3389/fmed.2025.1594450

4,709 views
3 citations

Original Research

Published on 31 Oct 2025

Considerations on the implementation of DCT: a SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan

in Regulatory Science

Hiroyuki Taruno
Koji Ikeda
Marika Oikawa
Takahiro Sato
Yuka Suzuki
Mayumi Shikano

Frontiers in Medicine

doi 10.3389/fmed.2025.1521135

1,932 views

Policy and Practice Reviews

Published on 23 Oct 2025

Early access disparities in innovative therapies across the US, EU, China, and Japan

in Regulatory Science

Sanae Akodad
Michel Goldman
Hilde Stevens

Frontiers in Medicine

doi 10.3389/fmed.2025.1642882

3,877 views
2 citations

Editorial

Published on 20 Oct 2025

Editorial: Reviews in: regulatory science 2024-2025

in Regulatory Science

Mette Due Theilade Thomsen
Lisbeth Ehlert Knudsen

Frontiers in Medicine

doi 10.3389/fmed.2025.1705977

2,816 views

Correction

Published on 17 Oct 2025

Correction: Harnessing the promises of cell therapy, gene therapy, and regenerative medicine in Québec, Canada

in Regulatory Science

Jean-Sébastien Delisle
Diane Fournier
Kim Santerre
Samuel Rochette
Ma'n H. Zawati
Maude Dumont-Lagacé
Simon Turcotte
Jason Robert Guertin
Patrick Vermette
Jacques P. Tremblay

Frontiers in Medicine

doi 10.3389/fmed.2025.1710876

1,278 views

Policy and Practice Reviews

Published on 16 Oct 2025

Reimagining drug regulation in the age of AI: a framework for the AI-enabled Ecosystem for Therapeutics

in Regulatory Science

Rominder Singh
Karen Zhou
Jared R. Auclair

Frontiers in Medicine

doi 10.3389/fmed.2025.1679611

4,255 views
2 citations

Original Research

Published on 15 Oct 2025

A model structure for describing uncertainties in benefit-risk assessment of oncology drug applications

in Regulatory Science

Nikolaos Zafiropoulos
Francesco Pignatti
Andreas Kouroumalis
Lorenzo Guizzaro
Dominik Karres
Pierre Demolis
Olli Tenhunen
Rosanne Janssens
Anne Taams
Lourens T. Bloem

Frontiers in Medicine

doi 10.3389/fmed.2025.1589578

3,697 views

Original Research

Published on 10 Oct 2025

A real-world data analysis of piroxicam in the FDA Adverse Event Reporting System (FAERS) database

in Regulatory Science

Yanhe Wang
Qiuhong Kong

Frontiers in Medicine

doi 10.3389/fmed.2025.1687088

1,807 views

Perspective

Published on 09 Oct 2025

The regulatory and scientific context in the study of the medicinal use of cannabis in Peru

in Regulatory Science

Pedro Wong-Salgado
Jeel Moya-Salazar
Hans Contreras-Pulache
Claudio Pardo-Villarroel

Frontiers in Medicine

doi 10.3389/fmed.2025.1598227

2,147 views

Systematic Review

Published on 02 Oct 2025

Concentration of propolis as a storage medium for avulsed teeth: a systematic review

in Regulatory Science

Chaya Chhabra
Kumar Gaurav Chhabra
Seemadevi Thangeswaran
Shraddha Shere

Frontiers in Medicine

doi 10.3389/fmed.2025.1583113

2,077 views
1 citation

Original Research

Published on 26 Sep 2025

Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US

in Regulatory Science

Giorgio Reggiardo
Alessandra Natale
Nicola Santoro
Viviana Giannuzzi
Claudia Pansieri
Mariagrazia Felisi
Donato Bonifazi
Adriana Ceci

Frontiers in Medicine

doi 10.3389/fmed.2025.1642279

2,067 views

516 articles

articles

The challenges of national health data ecosystems in feeding the European health data space: the Italian example

Blockchain-enabled quality by design system for clinical trials

The development of the neurosurgery workforce in Austria over the past quarter century: is more always better?

Post-marketing surveillance of upadacitinib: multilevel analysis of venous thromboembolism reporting in global data and rheumatoid arthritis

Awareness and practices of community pharmacists toward dextromethorphan misuse in Jeddah, Saudi Arabia: implications for regulation and public health

Nonclinical regulatory considerations for investigational new drug applications for regulatory T cell therapies

Influence of a multidirectional overground body weight support system on walking-related tasks in typically developing children and adolescents

A comparison of the labeling of antineoplastic and supportive medicines in China, Japan, and the US based on the WHO essential medicines list

The status quo of the development of decentralized clinical trials

The management of good manufacturing practice (GMP) inspections: a scoping review of the evidence

Assessment of compliance with good review practices by medicine assessors within the Zambia medicines regulatory authority

Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System

Herbal medicines adulteration with erectile dysfunction pharmaceuticals in sub-Saharan Africa: call to strengthen regulatory measures

Reducing misdiagnosis in AI-driven medical diagnostics: a multidimensional framework for technical, ethical, and policy solutions

Considerations on the implementation of DCT: a SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan

Early access disparities in innovative therapies across the US, EU, China, and Japan

Editorial: Reviews in: regulatory science 2024-2025

Correction: Harnessing the promises of cell therapy, gene therapy, and regenerative medicine in Québec, Canada

Reimagining drug regulation in the age of AI: a framework for the AI-enabled Ecosystem for Therapeutics

A model structure for describing uncertainties in benefit-risk assessment of oncology drug applications

A real-world data analysis of piroxicam in the FDA Adverse Event Reporting System (FAERS) database

The regulatory and scientific context in the study of the medicinal use of cannabis in Peru

Concentration of propolis as a storage medium for avulsed teeth: a systematic review

Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US