Frontiers in Medicine | Regulatory Science

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

167 views

Original Research

Accepted on 05 Mar 2025

Ethical Framework for Responsible Foundational Models in Medical Imaging

in Regulatory Science

Debesh Jha
Gorkem Durak
Abhijit Das
Jasmer Sanjotra
Onkar Susladkar
Suramyaa Sarkar
Ashish Rauniyar
Nikhil Kumar Tomar
Linkai Peng
Sirui Li

Frontiers in Medicine

doi 10.3389/fmed.2025.1544501

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

383 views

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

296 views

Original Research

Accepted on 03 Mar 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

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

347 views

Mini Review

Accepted on 26 Feb 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
Oxana Iliach
Sanja Stanisic
Geoff Fatzinger

Frontiers in Medicine

doi 10.3389/fmed.2025.1474087

Perspective

Accepted on 25 Feb 2025

Putting the Substance in Substantial Evidence: An Evidence-Based Approach to Flexible Drug Regulation

in Regulatory Science

Tania Bubela
Melanie McPhail
Christopher McCabe
Dean Regier

Frontiers in Medicine

doi 10.3389/fmed.2025.1337890

Perspective

Accepted on 25 Feb 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

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

642 views

Perspective

Accepted on 24 Feb 2025

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

in Regulatory Science

Nathalie Seigneuret

Frontiers in Medicine

doi 10.3389/fmed.2025.1553448

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

370 views

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

775 views

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

980 views

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

157 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

510 views

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Articles

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

Ethical Framework for Responsible Foundational Models in Medical Imaging

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

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

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

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

Putting the Substance in Substantial Evidence: An Evidence-Based Approach to Flexible Drug Regulation

The Innovative Health Initiative Public-Private Partnership: A Catalyst for Big Data-Driven Health Research and Innovation

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

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

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

"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