Original Research

Published on 13 May 2022

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

in Regulatory Science

Ki Young Huh
Sang-un Jeong
Seol Ju Moon
Min-Ji Kim
Wooseok Yang
Myeonggyu Jeong
Ildae Song
Yong-Geun Kwak
SeungHwan Lee
Min-Gul Kim

Frontiers in Medicine

doi 10.3389/fmed.2022.837197

2,249 views
10 citations

Perspective

Published on 13 May 2022

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations

in Regulatory Science

Laura I. Salazar-Fontana

Frontiers in Medicine

doi 10.3389/fmed.2022.855100

12,624 views
12 citations

Policy and Practice Reviews

Published on 10 May 2022

20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

in Regulatory Science

Gabrielle M. O’Sullivan
Joshua G. Philips
Heidi J. Mitchell
Michael Dornbusch
John E. J. Rasko

Frontiers in Medicine

doi 10.3389/fmed.2022.883434

10,329 views
2 citations

Original Research

Published on 06 May 2022

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

in Regulatory Science

Marc Maliepaard
Priscilla Nibi
Gabrièlla Nibi
Anna M. G. Pasmooij

Frontiers in Medicine

doi 10.3389/fmed.2022.893028

5,656 views
4 citations

Original Research

Published on 29 Apr 2022

Assessment of Knowledge Regarding Safety Profile, Use, and Boxed Warnings of Fluoroquinolones Among Healthcare Professionals in Saudi Arabia: A Potential Implication for Drug Regulatory Authorities

in Regulatory Science

Tauqeer Hussain Mallhi
Abdullah Salah Alanazi
Yusra Habib Khan
Nasser Hadal Alotaibi
Muhammad Salman
Abdulaziz Ibrahim Alzarea
Salah-Ud-Din Khan
Nabil K. Alruwaili
Alaa Salah Alenazi
Ahmed D. Alatawi

Frontiers in Medicine

doi 10.3389/fmed.2022.816320

2,861 views
1 citation

Systematic Review

Published on 27 Apr 2022

Non-Pharmacological Interventions for Minimizing Physical Restraints Use in Intensive Care Units: An Umbrella Review

in Regulatory Science

Nianqi Cui
Xiaoli Yan
Yuping Zhang
Dandan Chen
Hui Zhang
Qiong Zheng
Jingfen Jin

Frontiers in Medicine

doi 10.3389/fmed.2022.806945

8,220 views
10 citations

Brief Research Report

Published on 26 Apr 2022

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond

in Regulatory Science

Natalie M. Hendrikse
Jordi Llinares Garcia
Thorsten Vetter
Anthony J. Humphreys
Falk Ehmann

Frontiers in Medicine

doi 10.3389/fmed.2022.878942

4,518 views
9 citations

Original Research

Published on 25 Apr 2022

Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

in Regulatory Science

Tariro Sithole
Gugu Mahlangu
Stuart Walker
Sam Salek

Frontiers in Medicine

doi 10.3389/fmed.2022.898725

3,786 views
7 citations

Original Research

Published on 25 Apr 2022

Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

in Regulatory Science

Tariro Sithole
Gugu Mahlangu
Stuart Walker
Sam Salek

Frontiers in Medicine

doi 10.3389/fmed.2022.898743

3,329 views
9 citations

Policy Brief

Published on 15 Apr 2022

Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan

in Regulatory Science

Hideki Maeda
Daniel Bin Ng

Frontiers in Medicine

doi 10.3389/fmed.2022.864960

7,479 views
3 citations

Original Research

Published on 30 Mar 2022

Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea

in Regulatory Science

Kyung-Bok Son
Sylvia Park

Frontiers in Medicine

doi 10.3389/fmed.2022.869262

1,619 views

Original Research

Published on 28 Mar 2022

Medication Errors and Type 2 Diabetes Management: A Qualitative Exploration of Physicians' Perceptions, Experiences and Expectations From Quetta City, Pakistan

in Regulatory Science

Muhammad Kashif Habib
Muhammad Naeem Khan
Abdul Sadiq
Qaiser Iqbal
Abdul Raziq
Nafees Ahmad
Zaffar Iqbal
Sajjad Haider
Muhammad Anwar
Fazal ur Rehman Khilji

Frontiers in Medicine

doi 10.3389/fmed.2022.846530

3,335 views
3 citations

Perspective

Published on 22 Mar 2022

Bioethics and COVID-19: Considering the Social Determinants of Health

in Regulatory Science

Luca Valera
Rodrigo López Barreda

Frontiers in Medicine

doi 10.3389/fmed.2022.824791

3,704 views
2 citations

Original Research

Published on 09 Mar 2022

Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

in Regulatory Science

Liese Barbier
Allary Mbuaki
Steven Simoens
Paul Declerck
Arnold G. Vulto
Isabelle Huys

Frontiers in Medicine

doi 10.3389/fmed.2022.820755

10,502 views
21 citations

Original Research

Published on 02 Mar 2022

The Pivotal Role of Quality Technical Structures for Clinical Trials Oversight in the Achievement of Long-Term Capacity Strengthening Outcomes

in Regulatory Science

Solomon Owusu Sekyere
Ivana Škrnjug-Yudov
Alexander Pinz
Heidi Meyer
Christoph Conrad

Frontiers in Medicine

doi 10.3389/fmed.2022.772605

2,614 views
1 citation

Brief Research Report

Published on 02 Mar 2022

An Infodemic of Misinformation on Stem Cell Therapy Among the Population of Saudi Arabia: A Cross-Sectional Study

in Regulatory Science

Doaa Aboalola
Heba Badraiq
Rawiah Alsiary
Samer Zakri
Neda Aboulola
Loay Haneef
Dalal Malibari
Moayad Baadhaim
Khaled Alsayegh

Frontiers in Medicine

doi 10.3389/fmed.2022.789695

3,494 views
4 citations

Navigation group

Articles

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

A Regulatory Risk-Based Approach to ATMP/CGT Development: Integrating Scientific Challenges With Current Regulatory Expectations

20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

Assessment of Knowledge Regarding Safety Profile, Use, and Boxed Warnings of Fluoroquinolones Among Healthcare Professionals in Saudi Arabia: A Potential Implication for Drug Regulatory Authorities

Non-Pharmacological Interventions for Minimizing Physical Restraints Use in Intensive Care Units: An Umbrella Review

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond

Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward

Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan

Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea

Medication Errors and Type 2 Diabetes Management: A Qualitative Exploration of Physicians' Perceptions, Experiences and Expectations From Quetta City, Pakistan

Bioethics and COVID-19: Considering the Social Determinants of Health

Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

The Pivotal Role of Quality Technical Structures for Clinical Trials Oversight in the Achievement of Long-Term Capacity Strengthening Outcomes

An Infodemic of Misinformation on Stem Cell Therapy Among the Population of Saudi Arabia: A Cross-Sectional Study