Review

Published on 23 Dec 2022

Deprescribing as a strategy for improving safety of medicines in older people: Clinical and regulatory perspective

in Cardiovascular Drug Safety

Salvatore Crisafulli
Elisabetta Poluzzi
Carlotta Lunghi
Vincenzo Di Francesco
Luca Pellizzari
Luca Pasina
Chiara Elli
Francesco Trotta
Agnese Cangini
Caterina Trevisan

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1011701

3,746 views
8 citations

Policy and Practice Reviews

Published on 15 Dec 2022

Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

in Substance-Based Medical Devices

Sara Manellari
Maria Grazia Leone
Antonella Casiraghi
Chiara Grazia Milena Gennari
Paola Minghetti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1089965

3,421 views
1 citation

Protocols

Published on 09 Dec 2022

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

in Substance-Based Medical Devices

Roberto Cioeta
Andrea Cossu
Emiliano Giovagnoni
Marta Rigoni
Paola Muti

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.992359

3,945 views
5 citations

Perspective

Published on 07 Dec 2022

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

in Substance-Based Medical Devices

Guido Rasi
Alessandro Mugelli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1071620

3,324 views

Brief Research Report

Published on 14 Nov 2022

Evaluation of a natural language processing tool for extracting gender, weight, ethnicity, and race in the US food and drug administration adverse event reporting system

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Vivian Dang
Eileen Wu
Cindy M. Kortepeter
Michael Phan
Rongmei Zhang
Yong Ma
Monica A. Muñoz

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1020943

1,283 views
4 citations

Brief Research Report

Published on 10 Nov 2022

Exploring opportunities for AI supported medication error categorization: A brief report in human machine collaboration

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Allan Fong
Christopher Bonk
Varvara Vasilchenko
Suranjan De
Douglas Kovich
Jo Wyeth

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1021068

1,623 views
1 citation

Opinion

Published on 26 Oct 2022

Establishing patient safety monitoring in the benefit-risk paradigm for off-label and emergency use of medications for COVID-19: A pharmacovigilance perspective

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Marina A. Malikova
Gianluca Trifirò
Giorgio Racagni
Dennis Van Liew
Peggy Webster
Tejal S. Brahmbhatt

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1038235

948 views

Correction

Published on 26 Oct 2022

Corrigendum: Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

in Substance-Based Medical Devices

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1054972

732 views

Brief Research Report

Published on 25 Oct 2022

Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the CAESAR project)

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Giada Crescioli
Marco Finocchietti
Silvia Cascini
Olga Paoletti
David Franchini
Emiliano Cappello
Giulia Valdiserra
Francesco Sciancalepore
Maria Grazia Celani
Marco Tuccori

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1041275

2,479 views
5 citations

Original Research

Published on 19 Oct 2022

Putting external validation performance of major bleeding risk models into context

in Cardiovascular Drug Safety

Clair Blacketer
Jenna M. Reps
Lu Wang
Patrick B. Ryan
Zhong Yuan

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1034677

665 views

Original Research

Published on 10 Oct 2022

Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists

in Substance-Based Medical Devices

Roberto Cioeta
Paola Muti
Marta Rigoni
Luigi Morlando
Filippo Siragusa
Andrea Cossu
Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.969831

5,197 views
4 citations

Perspective

Published on 16 Sep 2022

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

in Substance-Based Medical Devices

Carmela Fimognari
Enrique Barrajón-Catalán
Cristina Luceri
Eleonora Turrini
Emanuel Raschi
Elisabetta Bigagli

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.1001614

1,569 views
4 citations

Perspective

Published on 02 Sep 2022

Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

in Substance-Based Medical Devices

Emiliano Giovagnoni

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.998114

3,405 views
4 citations

Opinion

Published on 15 Aug 2022

Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the EU commission proposal to harmonize HTA

in Advanced Methods in Pharmacovigilance and Pharmacoepidemiology

Lucia Gozzo
Kenneth Paterson
Olivier Wong
Francis Megerlin
Jan Geldmacher
Patrizia Popoli
Claudio Jommi
Frank-Ulrich Fricke
Oriol De Solà-Morales
Isao Kamae

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.970661

2,457 views
4 citations

Perspective

Published on 04 Jul 2022

Medical Devices Made of Substances: A New Challenge

in Substance-Based Medical Devices

Maria Grazia Leone

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.952013

6,127 views
5 citations

Perspective

Published on 28 Jun 2022

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

in Substance-Based Medical Devices

Stefano Stagi

Frontiers in Drug Safety and Regulation

doi 10.3389/fdsfr.2022.867143

3,470 views
2 citations

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Articles

Deprescribing as a strategy for improving safety of medicines in older people: Clinical and regulatory perspective

Medicinal products, medical devices, or accessories of medical devices: How to qualify gases for spirometry?

A new platform for post-marketing surveillance and real-world evidence data collection for substance-based medical devices

European Union Regulation on clinical trials and Regulation on medical devices: A common soil for future development

Evaluation of a natural language processing tool for extracting gender, weight, ethnicity, and race in the US food and drug administration adverse event reporting system

Exploring opportunities for AI supported medication error categorization: A brief report in human machine collaboration

Establishing patient safety monitoring in the benefit-risk paradigm for off-label and emergency use of medications for COVID-19: A pharmacovigilance perspective

Corrigendum: Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

Riluzole use in presence of contraindications in adults affected by amyotrophic lateral sclerosis and its off-label use in other motor neuron diseases: Findings from an Italian multicentre study (the CAESAR project)

Putting external validation performance of major bleeding risk models into context

Effectiveness and tolerability of Poliprotect, a natural mucosal protective agent for gastroesophageal reflux disease and dyspepsia: Surveys from patients, physicians, and pharmacists

New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

Substance-based medical devices made of natural substances: An opportunity for therapeutic innovation

Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the EU commission proposal to harmonize HTA

Medical Devices Made of Substances: A New Challenge

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics