Frontiers in Medicine | Regulatory Science

Original Research

Accepted on 15 Aug 2025

Analysis of Timelines for EAC Joint GMP Inspections, 2016-2022: A Pathway for Regulatory System Strengthening in Africa and Capacity Building of Less Resourced National Regulatory Authorities (NRAs)

in Regulatory Science

Jane Humphrey Mashingia
Noel Aineplan
Kari L Clase
Steven Bryn
Zita Ekeocha

Frontiers in Medicine

doi 10.3389/fmed.2025.1644446

Review

Published on 14 Aug 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

699 views

Original Research

Published on 13 Aug 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

851 views

Original Research

Accepted on 12 Aug 2025

Possibilities for Secondary Data Use of Electronic Health Records with WiseSpace De-identification

in Regulatory Science

Olga Vovk
Ali Ghasempour
Gunnar Piho
Peeter Ross

Frontiers in Medicine

doi 10.3389/fmed.2025.1639342

143 views

Editorial

Published on 12 Aug 2025

Editorial: Regulatory science and meta science as components of regulation of medical products and practices

in Regulatory Science

Barbara K. Redman
Christine Gispen-de Wied
Thalia Arawi

Frontiers in Medicine

doi 10.3389/fmed.2025.1664402

445 views

Perspective

Accepted on 11 Aug 2025

Who Moved My Scan? Early Adopter Experiences with Pre-and Post-Market Healthcare AI Regulation Challenges

in Regulatory Science

Aviad Raz
Yael Inbar
Netta Avnoon
Liat Milwidsky
Barkan Hofman
Asaf Honig
Ziv Paz

Frontiers in Medicine

doi 10.3389/fmed.2025.1651934

144 views

Case Report

Published on 11 Aug 2025

Birth-related long bone fractures in otherwise healthy newborns and medical professional liability: literature review and case presentation

in Regulatory Science

M. Trabucco Aurilio
L. Fava
M. Chisari
M. Bolcato

Frontiers in Medicine

doi 10.3389/fmed.2025.1589417

394 views

Editorial

Accepted on 08 Aug 2025

Editorial: Errors and Biases in Modern Healthcare: Public Health, Medico-legal and Risk Management Aspects

in Regulatory Science

Simone Grassi
Francesco Ausania
Davide Ferorelli
Francesco De Micco

Frontiers in Medicine

doi 10.3389/fmed.2025.1676522

197 views

Systematic Review

Published on 08 Aug 2025

Summary of the best evidence for the use of antiseptics at various surgical sites to prevent postoperative infections

in Regulatory Science

Qingqing Du
Shan Wu
Ziwei Jin
Li Ni

Frontiers in Medicine

doi 10.3389/fmed.2025.1630272

709 views

Review

Accepted on 06 Aug 2025

Transforming the Interrelated Nature of Human Psychoneuroendocrine Health and Endocrine Disrupting Compounds in our Planet's Water: From Wilhelm Waldeyer's Neuron Theory to an Artificial Intelligence Extension of the Human Body?

in Regulatory Science

Sophie Schweizer-Schubert
Götz von Waldeyer-Hartz
Susann-Elisabeth Schütze
Daniel Maringer
Aki Sebastian Ruhl
Jochen Kuckelkorn

Frontiers in Medicine

doi 10.3389/fmed.2025.1583203

Methods

Published on 05 Aug 2025

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

954 views

Perspective

Accepted on 31 Jul 2025

How Life-Cycle Real-World Evidence Can Bridge Evidentiary Gaps in Precision Oncology

in Regulatory Science

Emanuel Krebs
Deirdre Weymann
Tania Bubela
Dean Regier

Frontiers in Medicine

doi 10.3389/fmed.2025.1563950

254 views

Original Research

Published on 30 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

1,081 views

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

1,218 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

2,296 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

1,142 views