Frontiers in Medicine | Regulatory Science

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

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

150 views

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

179 views

Original Research

Accepted on 31 Mar 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

Opinion

Accepted on 28 Mar 2025

Ethical interventions: Revisiting the assessment tools for health-system pharmacists Authors

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

Original Research

Accepted on 28 Mar 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

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

250 views

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

290 views

Original Research

Accepted on 14 Mar 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 Florian Egger
Fahimeda Ali
Albert John Allen
Alysha Kristine Croker
Andrew John Davidson
Pamela Dicks
Saul Nicholas Faust
Dionna Jeter Green

Frontiers in Medicine

doi 10.3389/fmed.2025.1542408

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

356 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

652 views

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

453 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

659 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

454 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

503 views