Frontiers in Drug Safety and Regulation

Volume 5 - 2025

Original Research

Accepted on 02 Jun 2025

Identifying regulatory outcomes of non-interventional Post Authorisation Safety Studies in the European repository of studies using publicly available information

Mariana Ferreira Almas
Anna Girardi
Salvatore Crisafulli
Katarina Gvozdanovic
Katja Hakkarainen
Giulia Hyeraci
Wilhelmina Hoogendoorn
Bettina Rillmann
Giuseppe Roberto
Giacomo Vitturi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1574430

Methods

Published on 26 May 2025

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

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

770 views

Review

Published on 24 Apr 2025

Corticosteroids in lung cancer

Vesna Ćeriman Krstić
Milija Gajić
Leonida Djukanović
Dragana Jovanović

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1528468

647 views

Original Research

Published on 13 Mar 2025

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

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

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1476998

529 views

Editorial

Published on 11 Mar 2025

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

Deborah Layton
Laura Hester
Asieh Golozar

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1579171

851 views

Perspective

Published on 13 Feb 2025

Implementing tokenization in clinical research to expand real-world insights

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

1,429 views

Volume 4 - 2024

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

Emiliano Giovagnoni
Luisa Mattoli
Andrea Cossu
Vitalia Murgia

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1519142

1,174 views

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

Veronika Valdová
Vladimíra Štěpánová
Lenka Lapčíková

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1402684

1,277 views

Original Research

Published on 06 Jan 2025

Detection of nontoxic BoNT/A levels in post-facial Botox injection breastmilk

Helene Gu
Zhenyu Xu
Renata Koviazina
Pengcheng Tan
Changcheng Zheng
Ferdinand Kappes
Domna G. Kotsifaki
Fangrong Shen
Anastasia Tsigkou

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1480515

1,742 views

Review

Published on 18 Dec 2024

Important tool in our rare disease toolbox: hybrid retrospective-prospective natural history studies serve well as external comparators for rare disease studies

Chinenye Ugoji
Julien Heidt
Joan Largent
Emily Bratton
Laura Hester
Sareh Keshavarzi
Stuart Turner
Christina Mack

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1418050

1,492 views

Original Research

Published on 06 Dec 2024

Influence of differential source patterns in the detection of signals of disproportionate reporting for PARP inhibitors

Jordi Mestres

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1497116

897 views

Mini Review

Published on 13 Nov 2024

Integrating electronic health records with other data sources for postmarket drug safety signal identification: a review

Julie V. Kim
Sharon E. Davis
Michael E. Matheny
Joshua C. Smith

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1428831

1,133 views

Editorial

Published on 13 Nov 2024

Editorial: AI/ML in pharmacovigilance and pharmacoepidemiology

Wen Zou
Pantelis Natsiavas
Assaf Gottlieb

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1517365

1,217 views
1 citation

Perspective

Published on 30 Oct 2024

External comparator studies and the joint application of the estimand and target trial emulation frameworks

Gerd Rippin
Héctor Sanz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1409102

1,259 views

Opinion

Published on 18 Sep 2024

Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates

Tarek A. Hammad
Sasan Sabrdaran
Jean-Marie Heim

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1477516

1,579 views
1 citation

Original Research

Published on 17 Sep 2024

Demonstrating the principal mechanism of action of medical devices intended for vaginal use on reconstructed human vaginal epithelium: the case of two hyaluronic acid-containing devices

Marisa Meloni
Barbara De Servi
Francesco Carriero
Emmanuelle Simon O’Brien
Dounia Houamel
Philippe Deruelle
Vincent Castagné

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2024.1445519

1,225 views
1 citation