Frontiers in Medicine | Regulatory Science

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

6,884 views
16 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

21,720 views
32 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

20,394 views
7 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

6,687 views
9 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

7,080 views
12 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

7,352 views
20 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

4,177 views
9 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

6,988 views
6 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

11,369 views
34 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

3,893 views
15 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

3,249 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

9,082 views
12 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

2,581 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

3,222 views
6 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

48,053 views
41 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

1,986 views