Frontiers in Medicine | Regulatory Science

Original Research

Published on 30 Apr 2025

Navigating the landscape of legal medicine: a 4-year analysis of forensic consultations in an Italian hospital

in Regulatory Science

Paolo Visci
Gianmarco Sirago
Annachiara Vinci
Francesco Calò
Francesco De Micco
Marcello Benevento
Biagio Solarino
Alessandro Dell’Erba
Davide Ferorelli

Frontiers in Medicine

doi 10.3389/fmed.2025.1521195

1,641 views

Original Research

Published on 30 Apr 2025

Measuring the multidimensional reputation of a medicines regulatory agency: development and validation of a public-oriented scale

in Regulatory Science

Kyung-Bok Son

Frontiers in Medicine

doi 10.3389/fmed.2025.1570817

1,567 views

Original Research

Published on 17 Apr 2025

Study on knowledge, practices, and attitudes toward decentralized clinical trials among the clinical trial practitioners in China

in Regulatory Science

Yuanyuan Shi
Yujian Bao
Yu Pu
Junhao Jiang
Bo Yan
Hang Zheng

Frontiers in Medicine

doi 10.3389/fmed.2025.1513975

2,390 views

Original Research

Published on 15 Apr 2025

Accelerated therapeutic development during COVID-19: insights, regulatory strategies, and recommendations for future pandemic preparedness

in Regulatory Science

Miyuki Katayama
Mayumi Shikano

Frontiers in Medicine

doi 10.3389/fmed.2025.1482035

2,532 views
2 citations

Original Research

Published on 15 Apr 2025

Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application 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.2025.1542408

4,557 views
2 citations

Opinion

Published on 11 Apr 2025

Ethical interventions: revisiting the assessment tools for health-system pharmacists

in Regulatory Science

Hong Tham Pham
Ronald L. Castelino
Tyree H. Kiser
Toby C. Trujillo
Megan K. Fischer
Kim-Huong Truong-Nguyen
Bao-Chau Truong-Nguyen
Minh-Hoang Tran

Frontiers in Medicine

doi 10.3389/fmed.2025.1536044

1,558 views
1 citation

Mini Review

Published on 02 Apr 2025

Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies

in Regulatory Science

Fran Brown
Maximilian Vargas
Sanja Stanisic
Geoff Fatzinger
Oxana Iliach

Frontiers in Medicine

doi 10.3389/fmed.2025.1474087

3,621 views
1 citation

Perspective

Published on 01 Apr 2025

The Innovative Health Initiative public–private partnership: a catalyst for big data-driven health research and innovation

in Regulatory Science

Elisabetta Vaudano

Frontiers in Medicine

doi 10.3389/fmed.2025.1554948

3,562 views
4 citations

Original Research

Published on 01 Apr 2025

Lost and found: trends in litigation and compensation related to retained surgical foreign bodies

in Regulatory Science

Simone Grassi
Martina Focardi
Francesco Santori
Marta Guerini
Elisa Ferri
Giulia Ferretti
Ilenia Bianchi
Filomena Autieri
Vilma Pinchi

Frontiers in Medicine

doi 10.3389/fmed.2025.1526271

2,690 views
4 citations

Perspective

Published on 20 Mar 2025

Putting the substance in substantial evidence: an evidence-based approach to flexible drug regulation

in Regulatory Science

Emanuel Krebs
Tania Bubela
Melanie McPhail
Christopher McCabe
Dean A. Regier

Frontiers in Medicine

doi 10.3389/fmed.2025.1337890

1,761 views
1 citation

Original Research

Published on 17 Mar 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. M. Leufkens
Nicola Magrini
Francesco Nonino
Veronika J. Wirtz
Hendrika A. van den Ham

Frontiers in Medicine

doi 10.3389/fmed.2025.1517020

5,070 views
2 citations

Original Research

Published on 14 Mar 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

2,444 views

Perspective

Published on 14 Mar 2025

Advancing European paediatric research - the contribution of the Innovative Health Initiative

in Regulatory Science

Nathalie Seigneuret

Frontiers in Medicine

doi 10.3389/fmed.2025.1553448

2,348 views
2 citations

Review

Published on 12 Mar 2025

Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia

in Regulatory Science

Yesuneh Tefera Mekasha
Habtamu Getahun
Addisu Afrassa Tegegne
Gemmechu Hasen

Frontiers in Medicine

doi 10.3389/fmed.2025.1452875

4,931 views
2 citations

Review

Published on 05 Mar 2025

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

in Regulatory Science

Francisco D. Rodríguez-Gómez
Dominique Monferrer
Oriol Penon
Pilar Rivera-Gil

Frontiers in Medicine

doi 10.3389/fmed.2025.1544393

12,436 views
114 citations

Perspective

Published on 04 Mar 2025

Valuing patients’ high unmet need to drive innovative therapies 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

1,852 views

Perspective

Published on 28 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

3,120 views
6 citations

Review

Published on 25 Feb 2025

Data altruism and the “consent” question: a study into the “consent” models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data

in Regulatory Science

Maria Christofidou
Theodoros N. Arvanitis
Dipak Kalra
Nathan Lea
Mahsa Shabani
Pascal Coorevits

Frontiers in Medicine

doi 10.3389/fmed.2024.1489925

4,095 views

Editorial

Published on 21 Feb 2025

Editorial: Ecosystems-centered health and care innovation

in Regulatory Science

Adamantios Koumpis
Panagiotis D. Bamidis
Elisio Costa
Evdokimos Konstantinidis

Frontiers in Medicine

doi 10.3389/fmed.2025.1567993

2,204 views
1 citation

Review

Published on 20 Feb 2025

Defining the value proposition in diagnostic technology: challenges and opportunities for its understanding and development – a review with a multiperspective reflective analysis

in Regulatory Science

Tayana Soukup
Bernarda Zamora-Talaya
Shayan Bahadori
Rosario Luxardo
Patrick Kierkegaard
Omar Butt
Hannah Kettley-Linsell
Katerina-Vanessa Savva
Massimo Micocci
Shanshan Zhou

Frontiers in Medicine

doi 10.3389/fmed.2025.1498618

4,688 views
2 citations

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

29,636 views
5 citations

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

3,792 views
1 citation

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

5,033 views
1 citation

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

5,838 views

517 articles

articles

Navigating the landscape of legal medicine: a 4-year analysis of forensic consultations in an Italian hospital

Measuring the multidimensional reputation of a medicines regulatory agency: development and validation of a public-oriented scale

Study on knowledge, practices, and attitudes toward decentralized clinical trials among the clinical trial practitioners in China

Accelerated therapeutic development during COVID-19: insights, regulatory strategies, and recommendations for future pandemic preparedness

Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process

Ethical interventions: revisiting the assessment tools for health-system pharmacists

Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies

The Innovative Health Initiative public–private partnership: a catalyst for big data-driven health research and innovation

Lost and found: trends in litigation and compensation related to retained surgical foreign bodies

Putting the substance in substantial evidence: an evidence-based approach to flexible drug regulation

Medicines not recommended for inclusion in the who essential medicines list: a retrospective observational study

The therapeutic futility paradox: insights from oncological drug litigation in Ecuador

Advancing European paediatric research - the contribution of the Innovative Health Initiative

Situational analysis and future directions for medicine retail outlets: compliance with pharmaceutical regulatory standards in Ethiopia

Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

Valuing patients’ high unmet need to drive innovative therapies for inherited retinal degenerations: insights from the RIWC 2024 workshop on value

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

Data altruism and the “consent” question: a study into the “consent” models used under the GDPR and how the data altruism mechanism can act as a potential solution for the research community in the reuse of health data

Editorial: Ecosystems-centered health and care innovation

Defining the value proposition in diagnostic technology: challenges and opportunities for its understanding and development – a review with a multiperspective reflective analysis

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

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

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