Frontiers in Medicine | Regulatory Science

Original Research

Published on 19 Feb 2025

Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance

in Regulatory Science

Renato Ferreira-da-Silva
Mariana Fernandes Lobo
Ana Margarida Pereira
Manuela Morato
Jorge Junqueira Polónia
Inês Ribeiro-Vaz

Frontiers in Medicine

doi 10.3389/fmed.2025.1501921

291 views

Perspective

Accepted on 17 Feb 2025

Healthcare AI, explainability, and the human-machine relationship: a (not so) novel practical challenge

in Regulatory Science

Claudia Giorgetti
Giuseppe Contissa
Giuseppe Basile

Frontiers in Medicine

doi 10.3389/fmed.2025.1545409

Perspective

Accepted on 17 Feb 2025

Valuing patients' high unmet need to drive innovative solutions for inherited retinal degenerations: Insights from the RIWC 2024 workshop on Value

in Regulatory Science

Nabin Paudel
Avril Daly

Frontiers in Medicine

doi 10.3389/fmed.2025.1481670

Original Research

Accepted on 14 Feb 2025

"The Therapeutic Futility Paradox: Insights from Oncological Drug Litigation in Ecuador"

in Regulatory Science

María Belén Mena Ayala
Xavier Maldonado

Frontiers in Medicine

doi 10.3389/fmed.2025.1434524

125 views

Original Research

Published on 11 Feb 2025

Acceptance of artificial intelligence clinical assistant decision support system to prevent and control venous thromboembolism among healthcare workers: an extend Unified Theory of Acceptance and Use of Technology Model

in Regulatory Science

Jingxian Wang
Yun Zhou
Kai Tan
Zhigang Yu
You Li

Frontiers in Medicine

doi 10.3389/fmed.2025.1475577

201 views

Original Research

Published on 11 Feb 2025

Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process

in Regulatory Science

Breanne Stewart
Pirkko Lepola
Gunter F. Egger
Fahimeda Ali
Albert J. Allen
Alysha K. Croker
Andrew J. Davidson
Pamela Dicks
Saul N. Faust
Dionna Green

Frontiers in Medicine

doi 10.3389/fmed.2025.1539787

252 views

Editorial

Accepted on 10 Feb 2025

Bridging Gaps in Healthcare: Innovations, Ethics, and Ecosystemic Collaboration in Digital Transformation

in Regulatory Science

Adamantios Koumpis
Panagiotis D Bamidis
Elisio Costa
Evdokimos Konstantinidis

Frontiers in Medicine

doi 10.3389/fmed.2025.1567993

150 views

Review

Accepted on 10 Feb 2025

Regulatory Pathways and Guidelines for Nanotechnology-Enabled Health Products: A Comparative Review of EU and US Frameworks

in Regulatory Science

Francisco Diego Rodríguez Gómez
Dominique Monferrer
Oriol Penón
Pilar Rivera-Gil

Frontiers in Medicine

doi 10.3389/fmed.2025.1544393

Policy and Practice Reviews

Published on 10 Feb 2025

From guideline to practice: three years of ICH S11 insights and recommendations

in Regulatory Science

Diana Tavares
Hsiao-Tzu Chien
Maria Elzbieta Sheean
Peter Theunissen
Peter van Meer
Karen Van Malderen

Frontiers in Medicine

doi 10.3389/fmed.2025.1537001

384 views

Original Research

Accepted on 04 Feb 2025

MEDICINES NOT RECOMMENDED FOR INCLUSION IN THE WHO ESSENTIAL MEDICINES LIST: A RETROSPECTIVE OBSERVATIONAL STUDY

in Regulatory Science

Enrico Costa
Vittorio Del Grosso
Bernadette Cappello
Armando A Genazzani
Benedikt Huttner
Hubert G Leufkens
Nicola Magrini
Francesco Nonino
Veronika J. Wirtz
Rianne Van Den Ham

Frontiers in Medicine

doi 10.3389/fmed.2025.1517020

Systematic Review

Published on 31 Jan 2025

Re-analysis of the current status of clinical trial registration in China

in Regulatory Science

Shuwen Li
Jianhao Li
Wenjing Zeng
Zhicheng Li
Jietong Zhang
Siying Wang
Nenggui Xu
Zeli Li

Frontiers in Medicine

doi 10.3389/fmed.2024.1394803

448 views

Original Research

Published on 30 Jan 2025

Effects of the Paediatric Regulation funding on the development of off-patent medicines in children

in Regulatory Science

Lucia Ruggieri
Silvia Torretta
Viviana Giannuzzi
Alessandra Natale
Mariagrazia Felisi
Adriana Ceci
Fedele Bonifazi

Frontiers in Medicine

doi 10.3389/fmed.2024.1473862

330 views

Original Research

Published on 30 Jan 2025

Exploration of policy feedback mechanism for healthcare improvement in China: a grounded theory model

in Regulatory Science

Tuo-Dong Zhu
Ming-Jin Yang
Hao Wu

Frontiers in Medicine

doi 10.3389/fmed.2025.1496836

355 views

Policy Brief

Published on 27 Jan 2025

Challenges and ongoing initiatives towards better integrated EU scientific advice

in Regulatory Science

Iordanis Gravanis
Michael Berntgen
Spiros Vamvakas
Pierre Demolis
Paolo Foggi

Frontiers in Medicine

doi 10.3389/fmed.2025.1473346

334 views

Hypothesis and Theory

Published on 24 Jan 2025

A conceptual model and practical guidance for the development, administration, and evaluation of individualized therapies

in Regulatory Science

Lucie Perillat
Andrew McFadyen
Patricia Furlong
James Anderson

Frontiers in Medicine

doi 10.3389/fmed.2025.1493832

496 views

Perspective

Published on 23 Jan 2025

Navigating the potential and pitfalls of large language models in patient-centered medication guidance and self-decision support

in Regulatory Science

Serhat Aydin
Mert Karabacak
Victoria Vlachos
Konstantinos Margetis

Frontiers in Medicine

doi 10.3389/fmed.2025.1527864

599 views

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Articles

Network analysis of adverse event patterns following immunization with mRNA COVID-19 vaccines: real-world data from the European pharmacovigilance database EudraVigilance

Healthcare AI, explainability, and the human-machine relationship: a (not so) novel practical challenge

Valuing patients' high unmet need to drive innovative solutions for inherited retinal degenerations: Insights from the RIWC 2024 workshop on Value

"The Therapeutic Futility Paradox: Insights from Oncological Drug Litigation in Ecuador"

Acceptance of artificial intelligence clinical assistant decision support system to prevent and control venous thromboembolism among healthcare workers: an extend Unified Theory of Acceptance and Use of Technology Model

Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process

Bridging Gaps in Healthcare: Innovations, Ethics, and Ecosystemic Collaboration in Digital Transformation

Regulatory Pathways and Guidelines for Nanotechnology-Enabled Health Products: A Comparative Review of EU and US Frameworks

From guideline to practice: three years of ICH S11 insights and recommendations

MEDICINES NOT RECOMMENDED FOR INCLUSION IN THE WHO ESSENTIAL MEDICINES LIST: A RETROSPECTIVE OBSERVATIONAL STUDY

Re-analysis of the current status of clinical trial registration in China

Effects of the Paediatric Regulation funding on the development of off-patent medicines in children

Exploration of policy feedback mechanism for healthcare improvement in China: a grounded theory model

Challenges and ongoing initiatives towards better integrated EU scientific advice

A conceptual model and practical guidance for the development, administration, and evaluation of individualized therapies

Navigating the potential and pitfalls of large language models in patient-centered medication guidance and self-decision support