Original Research

Published on 23 Sep 2024

WHO-listed authorities (WLA) framework: transparent evidence-based approach for promoting regulatory reliance towards increased access to quality-assured medical products

in Regulatory Science

Alireza Khadem Broojerdi
Anna Laura Salvati
Mohammed Refaat Abdelfattah
Razieh Ostad Ali Dehaghi
Hiiti B. Sillo
Rogerio Gaspar

Frontiers in Medicine

doi 10.3389/fmed.2024.1467229

1,912 views

Policy Brief

Published on 17 Sep 2024

Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates

in Regulatory Science

Chieko Kurihara
Dirceu Greco
Ames Dhai
Kotone Matsuyama
Varvara Baroutsou

Frontiers in Medicine

doi 10.3389/fmed.2024.1432267

753 views

Original Research

Published on 17 Sep 2024

Evaluation of the review models and approval timelines of authorities participating in the East African Medicine Regulatory Harmonisation initiative: alignment and strategies for moving forward

in Regulatory Science

Nancy Ngum
Margareth Ndomondo-Sigonda
Rémy Habonimana
Fred Siyoi
Clarisse Irasabwa
Julia Ojukwu
Felchism Apolinary
Andrew Okello
Sabrina Ahmada
Stuart Walker

Frontiers in Medicine

doi 10.3389/fmed.2024.1438041

471 views

Perspective

Published on 16 Sep 2024

Paediatric formulations—part of the repurposing concept?

in Regulatory Science

Siri Wang
Viviana Giannuzzi

Frontiers in Medicine

doi 10.3389/fmed.2024.1456247

479 views

Systematic Review

Published on 16 Sep 2024

Characteristic of clinical trials related to traumatic brain injury registered on ClinicalTrials.gov over the past two decades (2004–2023)

in Regulatory Science

Ruili Guo
Qingya Yang
Xuan Zhou
Shining Li
Yao Liu

Frontiers in Medicine

doi 10.3389/fmed.2024.1435762

662 views

Original Research

Published on 06 Sep 2024

Robotics and AI into healthcare from the perspective of European regulation: who is responsible for medical malpractice?

in Regulatory Science

Francesco De Micco
Simone Grassi
Luca Tomassini
Gianmarco Di Palma
Giulia Ricchezze
Roberto Scendoni

Frontiers in Medicine

doi 10.3389/fmed.2024.1428504

1,186 views

Original Research

Published on 29 Aug 2024

Evaluation of good review practices in member authorities of the East African Medicines Regulatory Harmonisation initiative: strategies for alignment with African medicines agency

in Regulatory Science

Nancy Ngum
Margareth Ndomondo-Sigonda
Rémy Habonimana
Fred Siyoi
Clarisse Irasabwa
Julia Ojukwu
Felchism Apolinary
Andrew Okello
Sabrina Ahmada
Stuart Walker

Frontiers in Medicine

doi 10.3389/fmed.2024.1437970

487 views

Editorial

Published on 28 Aug 2024

Editorial: Healthcare in the age of sapient machines: physician decision-making autonomy faced with artificial intelligence. Ethical, deontological and compensatory aspects

in Regulatory Science

Filippo Gibelli
Giovanni Maio
Giovanna Ricci

Frontiers in Medicine

doi 10.3389/fmed.2024.1477371

610 views

Original Research

Published on 27 Aug 2024

Seeing the primary tumor because of all the trees: Cancer type prediction on low-dimensional data

in Regulatory Science

Julia Gehrmann
Devina Johanna Soenarto
Kevin Hidayat
Maria Beyer
Lars Quakulinski
Samer Alkarkoukly
Scarlett Berressem
Anna Gundert
Michael Butler
Ana Grönke

Frontiers in Medicine

doi 10.3389/fmed.2024.1396459

643 views

Original Research

Published on 27 Aug 2024

Medico-legal management of healthcare-associated infections: a cost-effectiveness analysis in an Italian tertiary hospital

in Regulatory Science

Simone Grassi
Maddalena Grazzini
Marta Guerini
Giorgio Bertana
Linda Pompeo
Diana Paolini
Fabrizio Niccolini
Martina Focardi
Vilma Pinchi

Frontiers in Medicine

doi 10.3389/fmed.2024.1430625

546 views

Original Research

Published on 21 Aug 2024

A conceptual framework on determinants of the integrated tuberculosis control model implementation in China

in Regulatory Science

Xi Chen
Jiani Zhou
Quan Yuan
Chunji Huang
Ying Li

Frontiers in Medicine

doi 10.3389/fmed.2024.1407131

751 views

Original Research

Published on 20 Aug 2024

Quality improvement in neonatal care through enhanced patient safety and clinical risk management: a before-and-after study about neonatal sepsis

in Regulatory Science

Davide Ferorelli
Vito Maria Goffredo
Elena Graziano
Maurizio Mastrapasqua
Michele Telegrafo
Annachiara Vinci
Paolo Visci
Marcello Benevento
Fiorenza Zotti
Alessandra Foglianese

Frontiers in Medicine

doi 10.3389/fmed.2024.1430853

787 views

Policy and Practice Reviews

Published on 16 Aug 2024

Disability 4.0: bioethical considerations on the use of embodied artificial intelligence

in Regulatory Science

Francesco De Micco
Vittoradolfo Tambone
Paola Frati
Mariano Cingolani
Roberto Scendoni

Frontiers in Medicine

doi 10.3389/fmed.2024.1437280

772 views

Original Research

Published on 14 Aug 2024

Game-theoretic analysis of governance and corruption in China's pharmaceutical industry

in Regulatory Science

Xi Wang
Tao Zhang
Hanxiang Gong
Jinghua Li
Baoling Wu
Baoxin Chen
Shufang Zhao

Frontiers in Medicine

doi 10.3389/fmed.2024.1439864

1,175 views

Original Research

Published on 12 Aug 2024

Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges

in Regulatory Science

Kenneth I. Aycock
Tom Battisti
Ashley Peterson
Jiang Yao
Steven Kreuzer
Claudio Capelli
Sanjay Pant
Pras Pathmanathan
David M. Hoganson
Steve M. Levine

Frontiers in Medicine

doi 10.3389/fmed.2024.1433372

3,052 views

Original Research

Published on 07 Aug 2024

In India, most principal investigators have run very few trials over the years

in Regulatory Science

Rishima Borah
Anwesha Dhal Samanta
Khujith Rajueni
Vina Vaswani
Gayatri Saberwal

Frontiers in Medicine

doi 10.3389/fmed.2024.1424570

1,117 views

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Articles

WHO-listed authorities (WLA) framework: transparent evidence-based approach for promoting regulatory reliance towards increased access to quality-assured medical products

Vulnerability, social value and the equitable sharing of benefits from research: beyond the placebo and access debates

Evaluation of the review models and approval timelines of authorities participating in the East African Medicine Regulatory Harmonisation initiative: alignment and strategies for moving forward

Paediatric formulations—part of the repurposing concept?

Characteristic of clinical trials related to traumatic brain injury registered on ClinicalTrials.gov over the past two decades (2004–2023)

Robotics and AI into healthcare from the perspective of European regulation: who is responsible for medical malpractice?

Evaluation of good review practices in member authorities of the East African Medicines Regulatory Harmonisation initiative: strategies for alignment with African medicines agency

Editorial: Healthcare in the age of sapient machines: physician decision-making autonomy faced with artificial intelligence. Ethical, deontological and compensatory aspects

Seeing the primary tumor because of all the trees: Cancer type prediction on low-dimensional data

Medico-legal management of healthcare-associated infections: a cost-effectiveness analysis in an Italian tertiary hospital

A conceptual framework on determinants of the integrated tuberculosis control model implementation in China

Quality improvement in neonatal care through enhanced patient safety and clinical risk management: a before-and-after study about neonatal sepsis

Disability 4.0: bioethical considerations on the use of embodied artificial intelligence

Game-theoretic analysis of governance and corruption in China's pharmaceutical industry

Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges

In India, most principal investigators have run very few trials over the years