Frontiers in Drug Safety and Regulation

Policy and Practice Reviews

Accepted on 19 Sep 2025

Early Access Disparities in Innovative Therapies Across the US, EU, China and Japan

in Pharmaceutical Policy and Regulation

Sanae Akodad
Michel Goldman
Hilde Stevens

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1642882

308 views

Opinion

Published on 16 Sep 2025

Rethinking drug safety signal detection and causality assessment in the age of AI: the risks of incomplete data and biased insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Priyanka Chhikara
Tarek A. Hammad

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1678074

1,498 views

Original Research

Published on 10 Sep 2025

Identifying regulatory outcomes of Non-interventional Post-Authorisation Safety Studies (PASS) in the European repository of studies using publicly available information

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

M. F. Almas
A. Girardi
S. Crisafulli
K. Gvozdanovic
K. M. Hakkarainen
G. Hyeraci
W. E. Hoogendoorn
B. Rillmann
G. Roberto
G. Vitturi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1574430

1,274 views

Perspective

Accepted on 02 Sep 2025

Leveraging Real-World Data for Safety Signal Detection and Risk Management in Pre-and Post-Market Settings

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Kathleen M Gavin
Matthew L Sundermann
Alethea Wieland

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1626822

546 views

Mini Review

Accepted on 25 Aug 2025

Tokenization Techniques for Privacy-Preserving Healthcare Data: Tokenization Nuts and Bolts

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Camille Cook

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1599217

539 views

Perspective

Published on 15 Aug 2025

A national pharmacovigilance centre perspective on pandemic preparedness - lessons learned from the COVID-19 pandemic

in Vaccine Safety and Regulation

Florence van Hunsel
Agnes Kant

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1644680

2,685 views

Clinical Trial

Published on 11 Aug 2025

Medication beliefs and adherence during and after pregnancy among women at risk for gestational hypertensive disorders

in Maternal-Fetal Medicine

Pauline Dreesen
Dorien Lanssens
Sandy Nouwen
Pauline Volders
Febe Janssen
Adelheid Soubry
Wilfried Gyselaers
Michael Ceulemans

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1610273

1,022 views

Editorial

Published on 28 Jul 2025

Editorial: Safety of corticosteroids in respiratory medicine

in Respiratory Drug Safety

Semra Bilaçeroğlu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1656299

1,236 views

Review

Published on 20 Jun 2025

Centralized daily drug management in clinical trial institutions and specific implementation plans

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Yu Tang
Xiaolong Fang

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1620314

1,284 views

Methods

Published on 26 May 2025

Federated learning: a privacy-preserving approach to data-centric regulatory cooperation

in Pharmaceutical Policy and Regulation

Alexander Horst
Paul Loustalot
Sanjeev Yoganathan
Ting Li
Joshua Xu
Weida Tong
David Schneider
Nicolas Löffler-Perez
Erminio Di Renzo
Michael Renaudin

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579922

2,311 views

Review

Published on 24 Apr 2025

Corticosteroids in lung cancer

in Respiratory Drug Safety

Vesna Ćeriman Krstić
Milija Gajić
Leonida Djukanović
Dragana Jovanović

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1528468

3,154 views

Original Research

Published on 13 Mar 2025

Developing decision support algorithm for hypertension medications for use in a digital therapeutic system

in Cardiovascular Drug Safety

Jeannie K. Lee
J. Skye Nicholas
Amani Albadawi
Kathleen C. Insel

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1476998

1,528 views

Editorial

Published on 11 Mar 2025

Editorial: External control arms for single-arm studies: methodological considerations and applications

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Deborah Layton
Laura Hester
Asieh Golozar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579171

1,758 views

Perspective

Published on 13 Feb 2025

Implementing tokenization in clinical research to expand real-world insights

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Chelsea Walters
Crystal S. Langlais
Eva E. Oakkar
Wilhelmina E. Hoogendoorn
James B. Coutcher
Mui Van Zandt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1519307

3,400 views

Review

Published on 17 Jan 2025

Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare

in Substance-Based Medical Devices

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

2,481 views
1 citation

Original Research

Published on 16 Jan 2025

The safety and efficacy of neutral electrolyzed water solution for wound irrigation: post-market clinical follow-up study

in Substance-Based Medical Devices

Veronika Valdová
Vladimíra Štěpánová
Lenka Lapčíková

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

2,503 views
1 citation