Frontiers in Medicine | Regulatory Science

Original Research

Published on 23 Dec 2021

The Role of EUPATI CH in Promoting Patient Involvement in Clinical Research: A Multi-Stakeholder Research Project

in Regulatory Science

Cristiana Sessa
Caecilia Schmid
Angela Tolotti
Annette Magnin
David Haerry
Loris Bonetti
Ingrid Klingmann

Frontiers in Medicine

doi 10.3389/fmed.2021.795659

2,946 views
4 citations

Original Research

Published on 20 Dec 2021

Medication Errors in Secondary Care Hospitals in Kuwait: The Perspectives of Healthcare Professionals

in Regulatory Science

Fatemah M. Alsaleh
Sara Alsaeed
Zahra K. Alsairafi
Noor B. Almandil
Abdallah Y. Naser
Tania Bayoud

Frontiers in Medicine

doi 10.3389/fmed.2021.784315

5,489 views
7 citations

Perspective

Published on 09 Dec 2021

Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

in Regulatory Science

Jorn Mulder
Robin Verjans
Ciska Verbaanderd
Elias Pean
Just Weemers
Hubert G. M. Leufkens
Francesco Pignatti
Anthonius de Boer
Emile E. Voest
Violeta V. Stoyanova-Beninska

Frontiers in Medicine

doi 10.3389/fmed.2021.790782

5,241 views
3 citations

Original Research

Published on 08 Dec 2021

The Assessment of the Innovativeness of a New Medicine in Italy

in Regulatory Science

Filomena Fortinguerra
Serena Perna
Roberto Marini
Alessandra Dell'Utri
Maurizio Trapanese
Francesco Trotta
Scientific & Technical Committee (Commissione Tecnico-Scientifica, CTS) of Italian Medicines Agency-AIFA

Frontiers in Medicine

doi 10.3389/fmed.2021.793640

9,217 views
7 citations

Perspective

Published on 03 Dec 2021

Supporting Decision Making in Intensive Care: Ethical Principles for Managing Access to Care During the COVID-19 Pandemic

in Regulatory Science

Stefano D'Errico
Martina Padovano
Matteo Scopetti
Federico Manetti
Martina Zanon
Alessandro Santurro
Paola Frati
Vittorio Fineschi

Frontiers in Medicine

doi 10.3389/fmed.2021.787805

2,806 views
3 citations

Editorial

Published on 26 Nov 2021

Editorial: Bioethics Amidst the COVID-19 Pandemic

in Regulatory Science

Maysa Al-Hussaini
Asem H. Mansour
Thalia A. Arawi
Ma'n H. Zawati
Haavi Morreim

Frontiers in Medicine

doi 10.3389/fmed.2021.778146

3,266 views
1 citation

General Commentary

Published on 24 Nov 2021

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

in Regulatory Science

Michael D. Abramoff
Zachary Mortensen
Chris Tava

Frontiers in Medicine

doi 10.3389/fmed.2021.765936

2,560 views
3 citations

Policy and Practice Reviews

Published on 23 Nov 2021

A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines

in Regulatory Science

Heraclio Rodriguez
Maria Lucia De Lucia

Frontiers in Medicine

doi 10.3389/fmed.2021.768376

4,107 views
1 citation

Original Research

Published on 22 Nov 2021

ASHA-Led Community-Based Groups to Support Control of Hypertension in Rural India Are Feasible and Potentially Scalable

in Regulatory Science

Michaela A. Riddell
G. K. Mini
Rohina Joshi
Amanda G. Thrift
Rama K. Guggilla
Roger G. Evans
Kavumpurathu R. Thankappan
Kate Chalmers
Clara K. Chow
Ajay S. Mahal

Frontiers in Medicine

doi 10.3389/fmed.2021.771822

6,434 views
13 citations

Perspective

Published on 19 Nov 2021

The EU Response to the Presence of Nitrosamine Impurities in Medicines

in Regulatory Science

Robin Ruepp
Roland Frötschl
Robert Bream
Maria Filancia
Thomas Girard
Andrei Spinei
Martina Weise
Rhys Whomsley

Frontiers in Medicine

doi 10.3389/fmed.2021.782536

17,729 views
19 citations

Original Research

Published on 17 Nov 2021

Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States

in Regulatory Science

Eldre W. Beukes
Gerhard Andersson
Vinaya Manchaiah

Frontiers in Medicine

doi 10.3389/fmed.2021.771646

4,527 views
4 citations

Policy and Practice Reviews

Published on 17 Nov 2021

Bridging the Gap: The Critical Role of Regulatory Affairs and Clinical Affairs in the Total Product Life Cycle of Pathology Imaging Devices and Software

in Regulatory Science

Staci J. Kearney
Amanda Lowe
Jochen K. Lennerz
Anil Parwani
Marilyn M. Bui
Katy Wack
Gina Giannini
Esther Abels

Frontiers in Medicine

doi 10.3389/fmed.2021.765385

8,927 views
11 citations

Original Research

Published on 12 Nov 2021

Process Evaluation of Internet-Based Cognitive Behavioral Therapy Intervention for Informal Caregivers

in Regulatory Science

Ieva Biliunaite
Evaldas Kazlauskas
Robbert Sanderman
Gerhard Andersson

Frontiers in Medicine

doi 10.3389/fmed.2021.725510

4,800 views
7 citations

Review

Published on 02 Nov 2021

Challenges During Review of COVID-19 Research Proposals: Experience of Faculty of Medicine, Ain Shams University Research Ethics Committee, Egypt

in Regulatory Science

Diaa Marzouk
Iman Sharawy
Isabelle Nakhla
Mostafa El Hodhod
Hoda Gadallah
Amr El-Shalakany
Reda Elwakil
Mohammed M. Moussa
Alaa Ismail
Fathy M. Tash

Frontiers in Medicine

doi 10.3389/fmed.2021.715796

3,925 views
7 citations

Original Research

Published on 01 Nov 2021

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency

in Regulatory Science

Laura Patricia Orellana García
Falk Ehmann
Philip A. Hines
Armin Ritzhaupt
Angela Brand

Frontiers in Medicine

doi 10.3389/fmed.2021.753187

15,139 views
23 citations

Perspective

Published on 27 Oct 2021

A Learning Health System Framework to Operationalize Health Data to Improve Quality Care: An Australian Perspective

in Regulatory Science

Joanne C. Enticott
Angela Melder
Alison Johnson
Angela Jones
Tim Shaw
Wendy Keech
Jim Buttery
Helena Teede

Frontiers in Medicine

doi 10.3389/fmed.2021.730021

10,497 views
26 citations