Frontiers | Regulatory Science: Addressing Uncertainties in Medicines Development, Evaluation and Use

Regulatory Science: Addressing Uncertainties in Medicines Development, Evaluation and Use

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ERRATUM

Published on 19 Sep 2024

Erratum: Assessing the credibility of a drug's effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

Frontiers Production Office

doi 10.3389/fmed.2024.1486408

152 views

ORIGINAL RESEARCH

Published on 17 Jul 2024

Assessing the credibility of a drug’s effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

Joyce M. Hoek
Jonna Brenninkmeijer
Ymkje Anna de Vries
Rob R. Meijer
Don van Ravenzwaaij

Assessing the credibility of a drug’s effects: identification and judgment of uncertainty by the Dutch Medicines Evaluation Board

doi 10.3389/fmed.2024.1409259

687 views
1 citation

POLICY BRIEF

Published on 24 Jun 2024

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

Mariia V. Maksimova
Ghislaine J. M. W. van Thiel
Yke Tromp
Rosan Lechner
Johannes J. M. van Delden
Lourens T. Bloem

Balancing ethical norms and duties for the introduction of new medicines through conditional marketing authorization: a research agenda

doi 10.3389/fmed.2024.1408553

1,024 views
1 citation

REVIEW

Published on 23 May 2024

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

Diogo Almeida
Denise Umuhire
Rosa Gonzalez-Quevedo
Ana António
Juan Garcia Burgos
Patrice Verpillat
Nathalie Bere
Bruno Sepodes
Carla Torre

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU

doi 10.3389/fmed.2024.1408636

3,137 views

MINI REVIEW

Published on 12 Apr 2024

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

Kevin Klein
Jens Heisterberg
Pieter Stolk

Synthetic polypeptides using a biologic as a reference medicinal product – the European landscape of regulatory approvals

doi 10.3389/fmed.2024.1335928

1,772 views

POLICY AND PRACTICE REVIEWS

Published on 06 Mar 2024

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators

Philipp Cimiano
Ben Collins
Maria Carmela De Vuono
Thierry Escudier
Jürgen Gottowik
Matthias Hartung
Mathias Leddin
Bikalpa Neupane
Raul Rodriguez-Esteban
3 more
Krzysztof Wieckowski

Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators

doi 10.3389/fmed.2024.1274688

3,792 views
1 citation

ORIGINAL RESEARCH

Published on 08 Feb 2024

Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

María Gordillo-Marañón
Gianmario Candore
Marta López-Fauqued
Katerina-Christina Deli
Loris Piccolo
Paolo Alcini
Tom Paternoster-Howe
Irene Rager
Robin Ruepp
Menno van der Elst

Predicting the submission frequency of periodic safety update reports: development and application of the EURD tool

doi 10.3389/fmed.2024.1299190

3,001 views

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