Frontiers in Medicine | Regulatory Science

Original Research

Published on 08 Nov 2023

Regulatory agilities impacting review timelines for Pfizer/BioNTech’s BNT162b2 mRNA COVID-19 vaccine: a retrospective study

in Regulatory Science

Prisha Patel
Judith C. Macdonald
Jayanthi Boobalan
Matthew Marsden
Ruben Rizzi
Marianne Zenon
Jinma Ren
Haitao Chu
Joseph C. Cappelleri
Satrajit Roychoudhury

Frontiers in Medicine

doi 10.3389/fmed.2023.1275817

9,770 views
4 citations

Hypothesis and Theory

Published on 30 Oct 2023

A concept for multi-winner tenders for medicinal products with balancing between efficient prices, long-term competition and sustainability of supply

in Regulatory Science

Gergely Németh
Mánuel László Mágó
Zoltán Kaló
Judit Lám
Tamás Balogh
Valentin Brodszky

Frontiers in Medicine

doi 10.3389/fmed.2023.1282698

3,915 views
6 citations

Policy and Practice Reviews

Published on 30 Oct 2023

Real-world evidence for regulatory decision-making: updated guidance from around the world

in Regulatory Science

Leah Burns
Nadege Le Roux
Robert Kalesnik-Orszulak
Jennifer Christian
Jennifer Dudinak
Frank Rockhold
Sean Khozin
John O’Donnell

Frontiers in Medicine

doi 10.3389/fmed.2023.1236462

13,750 views
20 citations

Perspective

Published on 27 Oct 2023

The philosophy of pharmaceutical regulation—Paternalism or freedom of choice?

in Regulatory Science

Jörg Mahlich
Sybille Riou
Matthieu Verry

Frontiers in Medicine

doi 10.3389/fmed.2023.1264021

2,271 views

Policy and Practice Reviews

Published on 27 Oct 2023

A study on the normative path of ethics review in China: based on the perspective of Panopticism

in Regulatory Science

Leqian Wu
Xiangjin Kong

Frontiers in Medicine

doi 10.3389/fmed.2023.1268046

1,669 views

Original Research

Published on 23 Oct 2023

Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities

in Regulatory Science

Lorraine Danks
Boitumelo Semete-Makokotlela
Kennedy Otwombe
Yashmika Parag
Stuart Walker
Sam Salek

Frontiers in Medicine

doi 10.3389/fmed.2023.1265058

4,178 views
5 citations

Original Research

Published on 12 Oct 2023

Chinese Clinical Trial Registry 13-year data collection and analysis: geographic distribution, financial support, research phase, duration, and disease categories

in Regulatory Science

Ruitai Fan
Yufei Zheng
Runze Zhou
Narasimha M. Beeraka
Olga A. Sukocheva
Ruiwen Zhao
Shijie Li
Xiang Zhao
Chunying Liu
Song He

Frontiers in Medicine

doi 10.3389/fmed.2023.1203346

3,947 views
3 citations

Original Research

Published on 12 Oct 2023

Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey

in Regulatory Science

Jean-Marc Hoffmann
Anette Blümle
Regina Grossmann
Henry Yau
Britta Lang
Cedric Bradbury

Frontiers in Medicine

doi 10.3389/fmed.2023.1252352

2,983 views
4 citations

Original Research

Published on 11 Oct 2023

Analysis of patients’ privacy and associated factors in the perioperative period

in Regulatory Science

Mingyang Tan
Hongyu Li
Xiaofei Wang

Frontiers in Medicine

doi 10.3389/fmed.2023.1242149

4,372 views
2 citations

Original Research

Published on 10 Oct 2023

Completeness of intervention description in invasive cardiology trials: an observational study of ClinicalTrials.gov registry and corresponding publications

in Regulatory Science

Viktoria Lišnić
Hishaam Ashraf
Marin Viđak
Ana Marušić

Frontiers in Medicine

doi 10.3389/fmed.2023.1276847

1,619 views
1 citation

Perspective

Published on 09 Oct 2023

Taking AIM at serious illness: implementing an access to investigational medicines expanded access program

in Regulatory Science

Meghan Morrison Joly
Terri L. Edwards
Rebecca N. Jerome
Alex Mainor
Gordon R. Bernard
Jill M. Pulley

Frontiers in Medicine

doi 10.3389/fmed.2023.1287449

1,936 views

Opinion

Published on 02 Oct 2023

The nexus of social alliances and diverse moral domains: a bedrock for participatory clinical research

in Regulatory Science

Johanna M. C. Blom
Veronica Rivi
Fabio Tascedda
Luca Pani

Frontiers in Medicine

doi 10.3389/fmed.2023.1250247

1,274 views
1 citation

Policy and Practice Reviews

Published on 22 Sep 2023

Rebalancing commercial and public interests in prioritizing biomedical, social and environmental aspects of health through defining and managing conflicts of interest

in Regulatory Science

Barbara K. Redman

Frontiers in Medicine

doi 10.3389/fmed.2023.1247258

9,428 views
10 citations

Original Research

Published on 21 Sep 2023

Evaluation of medication errors in nursing during the COVID-19 pandemic and their relationship with shift work at teaching hospitals: a cross-sectional study in Iran

in Regulatory Science

Abdolreza Gilavand
Negar Jafarian
Kourosh Zarea

Frontiers in Medicine

doi 10.3389/fmed.2023.1200686

6,980 views
5 citations

Review

Published on 19 Sep 2023

Bibliometric analysis of the current status and trends on medical hyperspectral imaging

in Regulatory Science

Sijia Jiang
Ding Ma
Xin Tan
Mingyu Yang
Qingbin Jiao
Liang Xu

Frontiers in Medicine

doi 10.3389/fmed.2023.1235955

3,889 views
7 citations

Policy and Practice Reviews

Published on 04 Sep 2023

What makes joint assessment procedures attractive to the innovative industry: successes, challenges, and proposed improvements

in Regulatory Science

Nevena Miletic
Sarah Adam
Jacqueline Acquah
Zainab Aziz
Angelika Joos
John M. Mwangi

Frontiers in Medicine

doi 10.3389/fmed.2023.1207954

4,361 views
3 citations