Original Research

Published on 27 Aug 2021

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

in Regulatory Science

Tariro Sithole
Gugu Mahlangu
Velma Capote
Tania Sitoie
Saren Shifotoka
Johannes Gaeseb
Lorraine Danks
Portia Nkambule
Alex Juma
Adam Fimbo

Frontiers in Medicine

doi 10.3389/fmed.2021.742200

5,353 views
8 citations

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

5,679 views
4 citations

Original Research

Published on 27 Aug 2021

PRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease

in Regulatory Science

Kam Wa Chan
Pak Wing Lee
Crystal Pui-sha Leung
Yee Kwan Law
Lucy Gao
Gary Chi-wang Chan
Wai Han Yiu
Tai Pong Lam
Sydney Chi-wai Tang

Frontiers in Medicine

doi 10.3389/fmed.2021.668913

4,552 views
11 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

45,209 views
5 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

6,222 views
15 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

20,548 views
26 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

18,942 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

5,896 views
7 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

6,351 views
11 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

6,697 views
19 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

3,718 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

6,360 views
4 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

9,919 views
29 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

3,463 views
12 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

2,888 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

8,356 views
11 citations

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Articles

Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward

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

PRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease

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