Frontiers in Medicine | Regulatory Science

Original Research

Published on 27 Aug 2021

Evaluation of the Good Review Practices 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
Silverani Padayachee
Tohlang Sehloho
Akida Khea
Adam Fimbo

Frontiers in Medicine

doi 10.3389/fmed.2021.742181

3,737 views
13 citations

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

6,356 views
9 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

5,320 views
12 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

6,157 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

48,585 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

7,142 views
17 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

22,309 views
33 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

21,069 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

7,038 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

7,339 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

7,740 views
24 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

4,422 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

7,289 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

12,029 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

4,092 views
16 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

3,454 views
8 citations