Frontiers in Drug Safety and Regulation

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

872 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

896 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

713 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

837 views

Original Research

Accepted on 25 Nov 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

133 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

607 views

Review

Accepted on 21 Nov 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
Stefano Polesello
Ursula Kirchmayer
Marco Milani
Francesca Russo
Michele Nicoletti
Giovanna Scroccaro
Paola De Ambrosis

Frontiers in Drug Safety and Regulation

206 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

874 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

841 views

Review

Accepted on 05 Nov 2025

Pharmacovigilance and Bioethics: The Importance of a Neglected Relationship

in Pharmaceutical Policy and Regulation

Giuseppe Alvaro
Richa Chhibber
Robert Fuentes

Frontiers in Drug Safety and Regulation

576 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

2,867 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

1,096 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

2,966 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

1,860 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

820 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

3,495 views