Frontiers in Medicine | Regulatory Science

Original Research

Published on 28 May 2021

A Mixed Methods Process Evaluation of a Clustered-Randomized Controlled Trial to Determine the Effects of Community-Based Dietary Sodium Reduction in Rural China

in Regulatory Science

Hongling Chu
Jing Zhang
Michael D. Fetters
Wenyi Niu
Huijuan Li
Nicole Li
Lijing L. Yan
Yanfang Wang
Yangfeng Wu

Frontiers in Medicine

doi 10.3389/fmed.2021.646576

4,844 views
3 citations

Methods

Published on 21 May 2021

iOntoBioethics: A Framework for the Agile Development of Bioethics Ontologies in Pandemics, Applied to COVID-19

in Regulatory Science

Mohammed Odeh
Faten F. Kharbat
Rana Yousef
Yousra Odeh
Dina Tbaishat
Nancy Hakooz
Rana Dajani
Asem Mansour

Frontiers in Medicine

doi 10.3389/fmed.2021.619978

5,439 views
9 citations

Policy and Practice Reviews

Published on 21 May 2021

Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution?

in Regulatory Science

Judith C. Macdonald
David C. Isom
Daniel D. Evans
Katy J. Page

Frontiers in Medicine

doi 10.3389/fmed.2021.660808

13,511 views
22 citations

Original Research

Published on 07 May 2021

Nurses' Ethics in the Care of Patients During the COVID-19 Pandemic

in Regulatory Science

Aladeen Alloubani
Wejdan Khater
Laila Akhu-Zaheya
Maysa Almomani
Safa Alashram

Frontiers in Medicine

doi 10.3389/fmed.2021.589550

29,042 views
24 citations

Original Research

Published on 12 Apr 2021

Standard Survey Data: Insights Into Private Sector Utilization

in Regulatory Science

Dominic Montagu
Nirali Chakraborty

Frontiers in Medicine

doi 10.3389/fmed.2021.624285

4,611 views
20 citations

Original Research

Published on 31 Mar 2021

Deficiencies in Planning Interventional Trial Registration of COVID-19 in China

in Regulatory Science

Xiaodan Li
Shengzhao Zhang
Yiling Zhou
Ying Liu
Youlian Zhou
Sheyu Li
Na Su

Frontiers in Medicine

doi 10.3389/fmed.2021.618185

2,725 views

Original Research

Published on 30 Mar 2021

Ethical Challenges Related to the Novel Coronavirus (COVID-19) Outbreak: Interviews With Professionals From Saudi Arabia

in Regulatory Science

Ghiath Alahmad
Hanie Richi
Ala'a BaniMustafa
Adel F. Almutairi

Frontiers in Medicine

doi 10.3389/fmed.2021.620444

29,976 views
7 citations

Original Research

Published on 22 Mar 2021

Whom Should Be Saved? A Proposed Ethical Framework for Allocating Scarce Medical Resources to COVID-19 Patients Using Fuzzy Logic

in Regulatory Science

Heba Saadeh
Maha Saadeh
Wesam Almobaideen

Frontiers in Medicine

doi 10.3389/fmed.2021.600415

6,528 views
1 citation

Original Research

Published on 11 Mar 2021

Sex Proportionality in Pre-clinical and Clinical Trials: An Evaluation of 22 Marketing Authorization Application Dossiers Submitted to the European Medicines Agency

in Regulatory Science

Marieke J. H. J. Dekker
Sieta T. de Vries
Carolien H. M. Versantvoort
Ellen G. E. Drost-van Velze
Mansi Bhatt
Peter J. K. van Meer
Ineke K. Havinga
Christine C. Gispen-de Wied
Peter G. M. Mol

Frontiers in Medicine

doi 10.3389/fmed.2021.643028

8,838 views
13 citations

Policy and Practice Reviews

Published on 09 Mar 2021

A Comparative Study for License Application Regulations on Proprietary Chinese Medicines in Hong Kong and Canada

in Regulatory Science

Linda L. D. Zhong
Wai Ching Lam
Fang Lu
Xu Dong Tang
Aiping Lyu
Zhaoxiang Bian
Heather Boon

Frontiers in Medicine

doi 10.3389/fmed.2021.617625

5,039 views
2 citations

Study Protocol

Published on 09 Mar 2021

Patient Preferences to Assess Value IN Gene Therapies: Protocol Development for the PAVING Study in Hemophilia

in Regulatory Science

Eline van Overbeeke
Brett Hauber
Sissel Michelsen
Michel Goldman
Steven Simoens
Isabelle Huys

Frontiers in Medicine

doi 10.3389/fmed.2021.595797

6,635 views
9 citations

Original Research

Published on 25 Feb 2021

Challenges in Transition From Childhood to Adulthood Care in Rare Metabolic Diseases: Results From the First Multi-Center European Survey

in Regulatory Science

Karolina M. Stepien
Beata Kieć-Wilk
Christina Lampe
Trine Tangeraas
Graziella Cefalo
Nadia Belmatoug
Rita Francisco
Mireia del Toro
Leona Wagner
Anne-Grethe Lauridsen

Frontiers in Medicine

doi 10.3389/fmed.2021.652358

9,801 views
49 citations

Original Research

Published on 23 Feb 2021

Factors Influencing Participation in COVID-19 Clinical Trials: A Multi-National Study

in Regulatory Science

Ahmed Samir Abdelhafiz
Samar Abd ElHafeez
Mohammad Adnan Khalil
Manal Shahrouri
Bandar Alosaimi
Raneem O. Salem
Mohamed Alorabi
Fatma Abdelgawad
Mamoun Ahram

Frontiers in Medicine

doi 10.3389/fmed.2021.608959

7,403 views
26 citations

Perspective

Published on 12 Feb 2021

Shortages Without Frontiers: Antimicrobial Drug and Vaccine Shortages Impact Far Beyond the Individual!

in Regulatory Science

Guillaume Beraud

Frontiers in Medicine

doi 10.3389/fmed.2021.593712

5,147 views
12 citations

Policy and Practice Reviews

Published on 03 Feb 2021

Medicine Shortages: From Assumption to Evidence to Action - A Proposal for Using the FMD Data Repositories for Shortages Monitoring

in Regulatory Science

François Bouvy
Mihai Rotaru

Frontiers in Medicine

doi 10.3389/fmed.2021.579822

6,581 views
7 citations

Original Research

Published on 02 Feb 2021

Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?

in Regulatory Science

Maddalena Toma
Mariagrazia Felisi
Donato Bonifazi
Fedele Bonifazi
Viviana Giannuzzi
Giorgio Reggiardo
Saskia de Wildt
Adriana Ceci
TEDDY European Network of Excellence for Paediatric Research

Frontiers in Medicine

doi 10.3389/fmed.2021.593281

12,505 views
39 citations