Frontiers in Drug Safety and Regulation

Original Research

Published on 29 Dec 2025

Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women

in Maternal-Fetal Medicine

Emeline Maisonneuve
Nicoletta Luxi
Chiara Bellitto
Francesco Ciccimarra
Monika Raethke
Florence van Hunsel
Thomas Lieber
Erik Mulder
Fabio Riefolo
Felipe Villalobos

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1689349

522 views

Original Research

Accepted on 19 Dec 2025

Hepatobiliary Adverse Drug Reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Elena–Mirabela Velișcu
Cecilia Cagnotta
Maria Giuseppa Sullo
Antonietta Anatriello
Francesco Salvo
Cristina Scavone

Frontiers in Drug Safety and Regulation

163 views

Mini Review

Published on 18 Dec 2025

Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Camille V. Cook

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1599217

1,061 views

Review

Published on 18 Dec 2025

A narrative review on the environmental impact of medicines: from water analysis and in vivo studies to prescribing appropriateness, based on European and Italian legal frameworks

in Pharmaceutical Policy and Regulation

Irene Cristini
Elisabetta Poluzzi
Federica Soardo
Salvatore Crisafulli
Stefano Polesello
Ursula Kirchmayer
Marco Milani
Francesca Russo
Michele Nicoletti
Giovanna Scroccaro

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1681648

652 views

Review

Published on 17 Dec 2025

Pharmacovigilance and bioethics: the importance of a neglected relationship

in Pharmaceutical Policy and Regulation

Giuseppe Alvaro
Michael Müller
Richa Chhibber
Robert Fuentes

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1698515

1,075 views

Case Report

Accepted on 15 Dec 2025

Dexamethasone-Induced Non-Hyperthyroid Hypokalemic Periodic Paralysis: A Case Report and Literature Review

in Clinical Drug Safety

Wanling Zhu
Li Huan
Tian zhan
Honglei Jia

Frontiers in Drug Safety and Regulation

109 views

Original Research

Published on 12 Dec 2025

A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data

in Respiratory Drug Safety

Baiqing Huang
Yirou Ma
Wenli Wang
Shaorui Gu
Xisheng Wang

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1721656

641 views

Review

Published on 01 Dec 2025

The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective

in Vaccine Safety and Regulation

Laurence Serradell
Antonella Fretta
Jenny Nachbar
Jill Dreyfus
Diana Garofalo
Arianna Lucini
Susan Mather
Daina Esposito
Anne-Laure Chabanon
Vincent Bauchau

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1650992

1,201 views
1 citation

Policy and Practice Reviews

Published on 01 Dec 2025

Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices

in Vaccine Safety and Regulation

Sonja Gandhi-Banga
Laurence Serradell
Deborah Layton
Jill Dreyfus
Nicolas Praet
Diana C. Garofalo
Vincent Bauchau
Scott P. Kelly
Lin Li

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1651090

1,301 views
1 citation

Review

Published on 26 Nov 2025

Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review

in Substance-Based Medical Devices

Joan D’souza
Mukesh Nandave
Ruth Blöchlinger

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1609455

998 views

Policy and Practice Reviews

Published on 26 Nov 2025

Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence

in Vaccine Safety and Regulation

Sarah C. MacDonald
Adrienne P. Guignard
Flor M. Munoz
Eileen O. Dareng
Kourtney J. Davis
Marina Amaral de Avila Machado
Shahar Shmuel
Laura Taddei
Lydie Marcelon

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1648854

1,175 views

Perspective

Published on 25 Nov 2025

The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response

in Vaccine Safety and Regulation

Brian O’Hare
Heba Ibrahim
Patrick Revelle

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1607642

945 views

Original Research

Published on 14 Nov 2025

Reporting rates of abnormal uterine bleeding after COVID-19 vaccination in South Korea

in Vaccine Safety and Regulation

Jae Min Lee
Seung Geun Yeo
Sung Soo Kim
Dong Choon Park

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1658412

1,152 views

Correction

Published on 07 Nov 2025

Correction: 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.2025.1729828

946 views

Perspective

Published on 17 Oct 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

3,678 views

Perspective

Published on 16 Oct 2025

Communicating medication risks in pregnancy: Towards shared decision making

in Maternal-Fetal Medicine

Ursula Winterfeld
Kenneth Hodson
Maya Berlin
Benoît Marin
Michael Ceulemans
Corinna Weber-Schoendorfer
François R. Girardin
David Baud
Béatrice Schaad
Alice Panchaud

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1712216

1,266 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

3,411 views
1 citation

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

2,075 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

3,835 views
1 citation

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

2,034 views

Editorial

Published on 28 Jul 2025

Editorial: Safety of corticosteroids in respiratory medicine

in Clinical Drug Safety

Semra Bilaçeroğlu

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1656299

2,013 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

2,039 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

5,205 views

Review

Published on 24 Apr 2025

Corticosteroids in lung cancer

in Clinical Drug Safety

Vesna Ćeriman Krstić
Milija Gajić
Leonida Djukanović
Dragana Jovanović

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2025.1528468

5,629 views

100 articles

articles

Cohort event monitoring of booster COVID-19 vaccine safety using patient-reported outcomes in pregnant women

Hepatobiliary Adverse Drug Reactions during treatment with olaparib: an analysis of data from the EudraVigilance reporting system

Tokenization techniques for privacy-preserving healthcare data: tokenization nuts and bolts

A narrative review on the environmental impact of medicines: from water analysis and in vivo studies to prescribing appropriateness, based on European and Italian legal frameworks

Pharmacovigilance and bioethics: the importance of a neglected relationship

Dexamethasone-Induced Non-Hyperthyroid Hypokalemic Periodic Paralysis: A Case Report and Literature Review

A real-world disproportionality analysis of roflumilast using the US food and drug administration adverse event reporting system data

The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective

Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices

Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review

Post-approval safety studies of vaccines in pregnancy: available regulatory guidance and next steps towards the more efficient generation of safety evidence

The role of MedDRA in global pharmacovigilance and public health during COVID-19: pandemic preparedness and response

Reporting rates of abnormal uterine bleeding after COVID-19 vaccination in South Korea

Correction: Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

Leveraging real-world data for safety signal detection and risk management in pre- and post-market settings

Communicating medication risks in pregnancy: Towards shared decision making

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

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

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

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

Editorial: Safety of corticosteroids in respiratory medicine

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

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

Corticosteroids in lung cancer