Frontiers in Medicine | Regulatory Science

Brief Research Report

Published on 24 Jul 2025

The route to financial sustainability of a large Public Private Partnership—the example of the clinical trial network conect4children (c4c)

in Regulatory Science

Laetitia Paumard
Heidrun Hildebrand
Marianne Engel
Pirkko Lepola
Esther Montero
Frank Tennigkeit
Magda Rosenmöller

Frontiers in Medicine

doi 10.3389/fmed.2025.1599997

517 views

Editorial

Accepted on 21 Jul 2025

Editorial: Regulatory Science and Meta Science as Components of Regulation of Medical Products and Practices

in Regulatory Science

Barbara Redman
Christine Gispen-de Wied
Thalia Arawi

Frontiers in Medicine

doi 10.3389/fmed.2025.1664402

217 views

Review

Published on 17 Jul 2025

A decade of review in global regulation and research of artificial intelligence medical devices (2015–2025)

in Regulatory Science

Siwen Zhang
Yujun Li
Wenxi Liu
Qi Chu
Shasha Wang
Jinyu Li
Yuwen Chen

Frontiers in Medicine

doi 10.3389/fmed.2025.1630408

1,525 views

Review

Accepted on 14 Jul 2025

Symptoms and adverse events in controlled human infection models

in Regulatory Science

Karen Götz
Poleta Luga
Jörg Rengel
Mei Masur
Marcela Juárez-Hernández
Isabelle Bekeredjian-Ding

Frontiers in Medicine

doi 10.3389/fmed.2025.1578560

170 views

Original Research

Published on 14 Jul 2025

Comparison of the review models and regulatory timelines of seven countries participating in the ECOWAS-MRH initiative: identifying opportunities for improvement

in Regulatory Science

Mercy Owusu-Asante
Delese Mimi Darko
Seth Seaneke
Aminata Nacoulma
Oula Ibrahim Olivier Traore
Mojisola Christianah Adeyeye
Abayomi Akinyemi
Coulibaly Assane
Clarisse Épse Kaul Meledje Clamoungou
Oumy Kalsoum Ndao

Frontiers in Medicine

doi 10.3389/fmed.2025.1587761

802 views

Original Research

Accepted on 10 Jul 2025

A Roadmap for Personalized Medicine: the findings of the IC2PerMed Project

in Regulatory Science

Flavia Beccia
Francesco Andrea Causio
Marzia Di Marcantonio
Ilda Hoxhaj
Chiara Cadeddu
Melissa Campagno
Lena Schleicher
Carmen Fotino
Maike Tauchert
Marta Lomazzi

Frontiers in Medicine

doi 10.3389/fmed.2025.1572921

191 views

Policy and Practice Reviews

Published on 10 Jul 2025

New medicines for childhood-onset systemic lupus erythematosus: an EU perspective on paediatric drug development

in Regulatory Science

Roberto De Lisa
Fernando de Andres-Trelles
Ralph Bax
Sara Galluzzo
Brian Alward
Andrew Thomson
Dominik Karres
Hermine I. Brunner
Nicolino Ruperto
Gunter F. Egger

Frontiers in Medicine

doi 10.3389/fmed.2025.1583140

1,045 views

Original Research

Published on 10 Jul 2025

Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU—summary of a Focus group discussion

in Regulatory Science

Stiina Aarum
Claudia Popp
Alexa Hunter
Miha Skvarc
Ilona Reischl
Hilke Zander
Joerg Zinserling
Petra van Leeuwen
Jonathan Sutch
Tim Chesworth

Frontiers in Medicine

doi 10.3389/fmed.2025.1593644

1,495 views

Original Research

Published on 10 Jul 2025

To treat or not to treat? Oncologists’ perceptions and experiences regarding overtreatment in end stage cancer patients

in Regulatory Science

Saritte Perlman
Aviad Raz
Pesach Shvartzman
Raphael Catane
Tamar Freud
Moriah E. Ellen

Frontiers in Medicine

doi 10.3389/fmed.2025.1607479

808 views

Editorial

Published on 10 Jul 2025

Editorial: The changing focus of regulatory frameworks around the globe and the opportunities for harmonization

in Regulatory Science

Armando Magrelli
Daniel J. O'Connor
Violeta Stoyanova-Beninska

Frontiers in Medicine

doi 10.3389/fmed.2025.1645278

1,047 views

Perspective

Published on 09 Jul 2025

Beyond human limits: the ethical, social, and regulatory implications of human enhancement

in Regulatory Science

Chiara Gerardi
Christodoulos Xinaris

Frontiers in Medicine

doi 10.3389/fmed.2025.1595213

860 views

Original Research

Accepted on 07 Jul 2025

Automatic extraction of SmPC document for IDMP data model construction using foundation LLM and RAG: a preliminary experiment for pharmaceutical regulatory affairs

in Regulatory Science

HOCINE KADI
Alaa Abdellatif
Daniel Isaac Kemajou Njamen
Florian PEREME

Frontiers in Medicine

doi 10.3389/fmed.2025.1598979

363 views

Methods

Accepted on 04 Jul 2025

Implementation of a Quality Management System for decentralized manufacturing of cell and gene therapy products -technical and regulatory considerations_ von der Leyen et al. -1 -Implementation of a Quality Management System for decentralized manufacturing of cell and gene therapy products -technical and regulatory considerations

in Regulatory Science

Heiko Von Der Leyen
Julio Delgado
Chaya Mazouz
Michael Schmitt
Vered Caplan

Frontiers in Medicine

doi 10.3389/fmed.2025.1591751

336 views

Original Research

Published on 04 Jul 2025

Towards a clinical pathway to food for special medical purpose in China: current progress based on a cross-sectional survey

in Regulatory Science

Jie Gong
Mengyan Wang
Jiankui Guo
Yishu Lyu
Dongyu Mu
Lei Shi
Wen Hu
Fengmei Yu

Frontiers in Medicine

doi 10.3389/fmed.2025.1538105

1,293 views

Systematic Review

Published on 01 Jul 2025

Global trends of big data analytics in health research: a bibliometric study

in Regulatory Science

Li Yao
Yan Liu
Tingrui Wang
Chunyan Han
Qiaoxing Li
Qinqin Li
Xiaoli You
Tingting Ren
Yinhua Wang

Frontiers in Medicine

doi 10.3389/fmed.2025.1456286

1,161 views

Original Research

Published on 26 Jun 2025

Impact of regulatory measures on the approval timelines of advanced therapy medicinal products by the European Medicines Agency

in Regulatory Science

Simonita Alaburde
Justinas Ivaska
Greta Kaspute
Tatjana Ivaskiene

Frontiers in Medicine

doi 10.3389/fmed.2025.1623689

910 views