Frontiers in Medicine | Regulatory Science

Policy and Practice Reviews

Published on 27 Aug 2021

Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

in Regulatory Science

Maria E. Sheean
Frauke Naumann-Winter
Giuseppe Capovilla
Maria Elisabeth Kalland
Eva Malikova
Segundo Mariz
Darius Matusevicius
Robert Nistico
Brigitte Schwarzer-Daum
Stelios Tsigkos

Frontiers in Medicine

doi 10.3389/fmed.2021.744625

6,965 views
6 citations

Review

Published on 25 Aug 2021

Implementation and Access to Pre-exposure Prophylaxis for Human Immunodeficiency Virus by Men Who Have Sex With Men in Europe

in Regulatory Science

Bruno Sepodes
João Rocha
Jorge Batista
Maria-Eduardo Figueira
František Dráfi
Carla Torre

Frontiers in Medicine

doi 10.3389/fmed.2021.722247

52,633 views
7 citations

Original Research

Published on 13 Aug 2021

Worldwide Assessment of Low- and Middle-Income Countries' Regulatory Preparedness to Approve Medical Products During Public Health Emergencies

in Regulatory Science

Alireza Khadem Broojerdi
Claudia Alfonso
Razieh Ostad Ali Dehaghi
Mohamed Refaat
Hiiti Baran Sillo

Frontiers in Medicine

doi 10.3389/fmed.2021.722872

8,461 views
20 citations

Policy and Practice Reviews

Published on 11 Aug 2021

Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

in Regulatory Science

Jeanne-Céleste Paquet
Sandrine P. Claus
Magali Cordaillat-Simmons
Wilfrid Mazier
Georges Rawadi
Laure Rinaldi
Frédéric Elustondo
Alice Rouanet

Frontiers in Medicine

doi 10.3389/fmed.2021.716266

25,118 views
44 citations

Perspective

Published on 09 Aug 2021

Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan

in Regulatory Science

Hideki Maeda

Frontiers in Medicine

doi 10.3389/fmed.2021.672095

22,985 views
10 citations

Methods

Published on 02 Aug 2021

Patient Preferences for Lung Cancer Treatments: A Study Protocol for a Preference Survey Using Discrete Choice Experiment and Swing Weighting

in Regulatory Science

Dario Monzani
Serena Petrocchi
Serena Oliveri
Jorien Veldwijk
Rosanne Janssens
Luca Bailo
Meredith Y. Smith
Ian Smith
Elise Schoefs
Kristiaan Nackaerts

Frontiers in Medicine

doi 10.3389/fmed.2021.689114

8,335 views
13 citations

Original Research

Published on 23 Jul 2021

“Patient Comfort Can Be Sacrificed for Patient Safety”—Perception and Practice Reported by Critical Care Nurses Toward Physical Restraints: A Qualitative Descriptive Study

in Regulatory Science

Nianqi Cui
Ruolin Qiu
Yuping Zhang
Jingfen Jin

Frontiers in Medicine

doi 10.3389/fmed.2021.573601

8,904 views
14 citations

Original Research

Published on 21 Jul 2021

Diagnosing Diabetic Retinopathy With Artificial Intelligence: What Information Should Be Included to Ensure Ethical Informed Consent?

in Regulatory Science

Frank Ursin
Cristian Timmermann
Marcin Orzechowski
Florian Steger

Frontiers in Medicine

doi 10.3389/fmed.2021.695217

9,130 views
32 citations

Review

Published on 09 Jul 2021

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

in Regulatory Science

T. J. Kasperbauer
Colin Halverson

Frontiers in Medicine

doi 10.3389/fmed.2021.686264

5,403 views
12 citations

Review

Published on 06 Jul 2021

Scientific Advances in Diabetes: The Impact of the Innovative Medicines Initiative

in Regulatory Science

Maria de Fátima Brito
Carla Torre
Beatriz Silva-Lima

Frontiers in Medicine

doi 10.3389/fmed.2021.688438

8,711 views
8 citations

Original Research

Published on 06 Jul 2021

Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study

in Regulatory Science

Rosanne Janssens
Tamika Lang
Ana Vallejo
Jayne Galinsky
Ananda Plate
Kate Morgan
Elena Cabezudo
Raija Silvennoinen
Daniel Coriu
Sorina Badelita

Frontiers in Medicine

doi 10.3389/fmed.2021.686165

14,098 views
37 citations

Original Research

Published on 01 Jul 2021

The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency

in Regulatory Science

Marieke J. H. J. Dekker
Pieter Stolk
Anna M. G. Pasmooij

Frontiers in Medicine

doi 10.3389/fmed.2021.619513

5,096 views
17 citations

Systematic Review

Published on 28 Jun 2021

Association Between Prospective Registration and Quality of Systematic Reviews in Type 2 Diabetes Mellitus: A Meta-epidemiological Study

in Regulatory Science

Qiuyi Zheng
Fenghua Lai
Bin Li
Jia Xu
Jianyan Long
Sui Peng
Yanbing Li
Yihao Liu
Haipeng Xiao

Frontiers in Medicine

doi 10.3389/fmed.2021.639652

4,117 views
8 citations

Review

Published on 25 Jun 2021

Regulatory Standards in Orphan Medicinal Product Designation in the EU

in Regulatory Science

Stelios Tsigkos
Segundo Mariz
Maria Elzbieta Sheean
Kristina Larsson
Armando Magrelli
Violeta Stoyanova-Beninska

Frontiers in Medicine

doi 10.3389/fmed.2021.698534

10,358 views
17 citations

Perspective

Published on 17 Jun 2021

Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials

in Regulatory Science

Roberto Truzoli
Phil Reed
Lisa A. Osborne

Frontiers in Medicine

doi 10.3389/fmed.2021.648403

3,317 views
4 citations

Original Research

Published on 31 May 2021

Evaluation of Consistency of Treatment Response Across Regions—the LEADER Trial in Relation to the ICH E17 Guideline

in Regulatory Science

Henrik K. Nielsen
Stephanie DeChiaro
Bryan Goldman

Frontiers in Medicine

doi 10.3389/fmed.2021.662775

4,581 views
7 citations

Original Research

Published on 31 May 2021

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

in Regulatory Science

Meng Li
Shengqi Chen
Yunfeng Lai
Zuanji Liang
Jiaqi Wang
Junnan Shi
Haojie Lin
Dongning Yao
Hao Hu
Carolina Oi Lam Ung

Frontiers in Medicine

doi 10.3389/fmed.2021.669509

51,794 views
53 citations

Brief Research Report

Published on 28 May 2021

Evaluation of Eight-Item Vancomycin Prescribing Confidence Questionnaire Among Junior Doctors

in Regulatory Science

Lu Liu
Zhehan Jiang
Ana Xie
Weimin Wang

Frontiers in Medicine

doi 10.3389/fmed.2021.677818

2,642 views

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

6,261 views
6 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

6,576 views
10 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

16,645 views
34 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

31,804 views
28 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

5,933 views
23 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

3,557 views

518 articles

articles

Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

Implementation and Access to Pre-exposure Prophylaxis for Human Immunodeficiency Virus by Men Who Have Sex With Men in Europe

Worldwide Assessment of Low- and Middle-Income Countries' Regulatory Preparedness to Approve Medical Products During Public Health Emergencies

Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

Medical Affairs in Pharmaceutical Companies and Related Pharmaceutical Regulations in Japan

Patient Preferences for Lung Cancer Treatments: A Study Protocol for a Preference Survey Using Discrete Choice Experiment and Swing Weighting

“Patient Comfort Can Be Sacrificed for Patient Safety”—Perception and Practice Reported by Critical Care Nurses Toward Physical Restraints: A Qualitative Descriptive Study

Diagnosing Diabetic Retinopathy With Artificial Intelligence: What Information Should Be Included to Ensure Ethical Informed Consent?

Adolescent Assent and Reconsent for Biobanking: Recent Developments and Emerging Ethical Issues

Scientific Advances in Diabetes: The Impact of the Innovative Medicines Initiative

Patient Preferences for Multiple Myeloma Treatments: A Multinational Qualitative Study

The Use of Remote Monitoring Technologies: A Review of Recent Regulatory Scientific Advices, Qualification Opinions, and Qualification Advices Issued by the European Medicines Agency

Association Between Prospective Registration and Quality of Systematic Reviews in Type 2 Diabetes Mellitus: A Meta-epidemiological Study

Regulatory Standards in Orphan Medicinal Product Designation in the EU

Patient Expectations of Assigned Treatments Impact Strength of Randomised Control Trials

Evaluation of Consistency of Treatment Response Across Regions—the LEADER Trial in Relation to the ICH E17 Guideline

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Evaluation of Eight-Item Vancomycin Prescribing Confidence Questionnaire Among Junior Doctors

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

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

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

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

Standard Survey Data: Insights Into Private Sector Utilization

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