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

2,174 views
1 citation

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

3,613 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

5,401 views
11 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

16,701 views
16 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

3,154 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

7,250 views
10 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

4,262 views
6 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

3,518 views
5 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

13,631 views
18 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

8,983 views
18 citations

Review

Published on 26 Oct 2021

R&D Costs of New Medicines: A Landscape Analysis

in Regulatory Science

Steven Simoens
Isabelle Huys

Frontiers in Medicine

doi 10.3389/fmed.2021.760762

26,899 views
44 citations

Original Research

Published on 22 Oct 2021

Process Evaluation of an Online SUpport PRogram for Older Hearing Aid Users Delivered in a Cluster Randomized Controlled Trial

in Regulatory Science

Janine F. J. Meijerink
Marieke Pronk
Birgit I. Lissenberg-Witte
Vera Jansen
Sophia E. Kramer

Frontiers in Medicine

doi 10.3389/fmed.2021.725388

2,249 views

Brief Research Report

Published on 11 Oct 2021

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity

in Regulatory Science

Ai Fukaya-Shiba
Kouhei Otsuka
Hajime Sasaki
Mayumi Shikano
Rika Wakao

Frontiers in Medicine

doi 10.3389/fmed.2021.756870

4,585 views
2 citations

Review

Published on 11 Oct 2021

Network Meta-Analysis of 10 Storage Mediums for Preserving Avulsed Teeth

in Regulatory Science

Na Zhang
Yuzhao Cheng
Fenglan Li
Qian Kang

Frontiers in Medicine

doi 10.3389/fmed.2021.749278

6,845 views
1 citation

Systematic Review

Published on 04 Oct 2021

Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020)

in Regulatory Science

Wen-Wen Wu
Xing Ji
Hao Wang
Feng Chen
Qian Ding
Guan-dong Zhang
Man Li
Shan-shan Wang
Ming-ming Ni
Qing-qing Liu

Frontiers in Medicine

doi 10.3389/fmed.2021.745676

3,659 views
4 citations

Original Research

Published on 09 Sep 2021

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities

in Regulatory Science

Hasumati Rahalkar
Alan Sheppard
Gustavo Mendes Lima Santos
Chitralekha Dasgupta
Sonia Mayra Perez-Tapia
Carlos A. Lopez-Morales
Sam Salek

Frontiers in Medicine

doi 10.3389/fmed.2021.726660

20,523 views
10 citations

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Articles

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

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

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

The EU Response to the Presence of Nitrosamine Impurities in Medicines

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

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

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

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

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

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

R&D Costs of New Medicines: A Landscape Analysis

Process Evaluation of an Online SUpport PRogram for Older Hearing Aid Users Delivered in a Cluster Randomized Controlled Trial

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity

Network Meta-Analysis of 10 Storage Mediums for Preserving Avulsed Teeth

Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020)

Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities