Frontiers in Medicine | Regulatory Science

Original Research

Published on 05 Apr 2024

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation

in Regulatory Science

Claudia P. Alfonso
Guy B. N’Jambong
Alaa Magdy
Laura Di Trapani
Rutendo Kuwana
Abraham G. Kahsay
Diadié Maïga
Sybil N. A. Ossei-Agyeman-Yeboah
Aimé B. Djitafo Fah
Margareth Ndomondo-Sigonda

Frontiers in Medicine

doi 10.3389/fmed.2024.1362253

3,506 views
1 citation

Policy Brief

Published on 02 Apr 2024

Declaration of Helsinki: ethical norm in pursuit of common global goals

in Regulatory Science

Chieko Kurihara
Sandor Kerpel-Fronius
Sander Becker
Anthony Chan
Yasmin Nagaty
Shehla Naseem
Johanna Schenk
Kotone Matsuyama
Varvara Baroutsou

Frontiers in Medicine

doi 10.3389/fmed.2024.1360653

5,495 views
13 citations

Original Research

Published on 28 Mar 2024

Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective

in Regulatory Science

Viviana Giannuzzi
Arianna Bertolani
Silvia Torretta
Giorgio Reggiardo
Eleonora Toich
Donato Bonifazi
Adriana Ceci

Frontiers in Medicine

doi 10.3389/fmed.2024.1369547

2,932 views
2 citations

Hypothesis and Theory

Published on 28 Mar 2024

Physician’s autonomy in the face of AI support: walking the ethical tightrope

in Regulatory Science

Florian Funer
Urban Wiesing

Frontiers in Medicine

doi 10.3389/fmed.2024.1324963

2,890 views
2 citations

Original Research

Published on 21 Mar 2024

Methodological biases in observational hospital studies of COVID-19 treatment effectiveness: pitfalls and potential

in Regulatory Science

Oksana Martinuka
Derek Hazard
Hamid Reza Marateb
Marjan Mansourian
Miguel Ángel Mañanas
Sergio Romero
Manuel Rubio-Rivas
Martin Wolkewitz

Frontiers in Medicine

doi 10.3389/fmed.2024.1362192

3,114 views
5 citations

Editorial

Published on 18 Mar 2024

Editorial: Current priorities in health research agendas: tensions between public and commercial interests in prioritizing biomedical, social, and environmental aspects of health

in Regulatory Science

Mercedes García Carrillo
Marc-André Gagnon
Matías Blaustein

Frontiers in Medicine

doi 10.3389/fmed.2024.1391982

1,337 views
1 citation

Original Research

Published on 11 Mar 2024

Addressing bias in the definition of SARS-CoV-2 reinfection: implications for underestimation

in Regulatory Science

Hiam Chemaitelly
Houssein H. Ayoub
Patrick Tang
Hadi M. Yassine
Asmaa A. Al Thani
Mohammad R. Hasan
Peter Coyle
Zaina Al-Kanaani
Einas Al-Kuwari
Andrew Jeremijenko

Frontiers in Medicine

doi 10.3389/fmed.2024.1363045

2,084 views
5 citations

Editorial

Published on 08 Mar 2024

Editorial: Women in science - regulatory science 2023

in Regulatory Science

Mette Due Theilade Thomsen
Lisbeth Ehlert Knudsen

Frontiers in Medicine

doi 10.3389/fmed.2024.1389438

1,078 views

Original Research

Published on 06 Mar 2024

Exploring the divergence in perspectives on clinical trial operations in South Korea during the COVID-19 pandemic: a comparison of a trial site and sponsors

in Regulatory Science

Young-Sang Kim
Anhye Kim
Yil-Seob Lee

Frontiers in Medicine

doi 10.3389/fmed.2024.1342184

4,408 views

Policy and Practice Reviews

Published on 06 Mar 2024

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators

in Regulatory Science

Philipp Cimiano
Ben Collins
Maria Carmela De Vuono
Thierry Escudier
Jürgen Gottowik
Matthias Hartung
Mathias Leddin
Bikalpa Neupane
Raul Rodriguez-Esteban
Ana Lucia Schmidt

Frontiers in Medicine

doi 10.3389/fmed.2024.1274688

5,411 views
9 citations

Editorial

Published on 27 Feb 2024

Editorial: Reproductive medical care in minors: ethical and liability issues

in Regulatory Science

Mariano Cingolani
Vittoradolfo Tambone

Frontiers in Medicine

doi 10.3389/fmed.2024.1378211

1,658 views

Original Research

Published on 19 Feb 2024

Forecasting the potential impact of cell and gene therapies in France: projecting product launches and patients treated

in Regulatory Science

Ming Kei Lee
Sama Seyedmousavi
Sylvain Auvity
Bertrand Pourroy
Vincent Elleboode
Isabelle Kachaner
Christel Jansen
Herve Lilliu

Frontiers in Medicine

doi 10.3389/fmed.2024.1324602

3,512 views
2 citations

Original Research

Published on 15 Feb 2024

Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match

in Regulatory Science

Iqbal S. Bhalla
Adithi Gopadi Ravindranath
Ravi Vaswani
Gayatri Saberwal

Frontiers in Medicine

doi 10.3389/fmed.2024.1346208

2,102 views
2 citations

Original Research

Published on 15 Feb 2024

Assessment of the extent and monetary loss in the selected public hospitals in Jimma Zone, Ethiopia: expired medicine perspectives

in Regulatory Science

Habtamu Getahun
Sileshi Belew
Gemmechu Hasen
Yesuneh Tefera Mekasha
Sultan Suleman

Frontiers in Medicine

doi 10.3389/fmed.2024.1283070

3,228 views
5 citations

Original Research

Published on 08 Feb 2024

Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

in Regulatory Science

María Gordillo-Marañón
Gianmario Candore
Marta López-Fauqued
Katerina-Christina Deli
Loris Piccolo
Paolo Alcini
Tom Paternoster-Howe
Irene Rager
Robin Ruepp
Menno van der Elst

Frontiers in Medicine

doi 10.3389/fmed.2024.1299190

3,890 views

Perspective

Published on 31 Jan 2024

Unlocking the potential of big data and AI in medicine: insights from biobanking

in Regulatory Science

Kaya Akyüz
Mónica Cano Abadía
Melanie Goisauf
Michaela Th. Mayrhofer

Frontiers in Medicine

doi 10.3389/fmed.2024.1336588

4,189 views
4 citations