Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks

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• dc.contributor.author Rodríguez-Gómez, Francisco D.
• dc.contributor.author Monferrer, Dominique
• dc.contributor.author Penon, Oriol
• dc.contributor.author Rivera Gil, Pilar, 1976-
• dc.date.accessioned 2025-11-10T14:32:38Z
• dc.date.available 2025-11-10T14:32:38Z
• dc.date.issued 2025
• dc.date.updated 2025-11-10T14:32:38Z
• dc.description.abstract The integration of nanotechnology into healthcare has introduced Nanotechnology-Enabled Health Products (NHPs), promising revolutionary advancements in medical treatments and diagnostics. Despite their potential, the regulatory navigation for these products remains complex and often lagging, creating barriers to their clinical application. This review article focuses on dissecting the regulatory landscape for NHPs, particularly in the European Union and the United States, to identify applicable requirements and the main regulatory guidelines currently available for meeting regulatory expectations.
• dc.description.sponsorship The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by the Industrial Doctorates Plan of the Department of Research and Universities of the Generalitat de Catalunya (Grant n° 202015). PRG acknowledges the Ministry of Science, Innovation and Universities (MICINN-AEI) (AEI-PID2022-140423NB-I00/AEI/10.13039/501100011033, CNS2023 - 143700) and the AGAUR (2021 SGR 00175 and 2021 PROD 00041) for financial support.
• dc.format.mimetype application/pdf
• dc.identifier.citation Rodriguez-Gomez FD, Monferrer D, Penon O, Rivera-Gil P. Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks. Front Med (Lausanne). 2025 Mar 5:12:1544393. DOI: 10.3389/fmed.2025.1544393
• dc.identifier.doi http://dx.doi.org/10.3389/fmed.2025.1544393
• dc.identifier.issn 2296-858X
• dc.identifier.uri http://hdl.handle.net/10230/71834
• dc.language.iso eng
• dc.publisher Frontiers
• dc.relation.ispartof Frontiers in Medicine. 2025;12:1544393
• dc.relation.projectID info:eu-repo/grantAgreement/ES/3PE/PID2022-140423NB-I00
• dc.rights © 2025 Rodríguez-Gómez, Monferrer, Penon and Rivera-Gil. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. http://creativecommons.org/licenses/by/4.0/
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword Nanotechnology-enabled health products
• dc.subject.keyword Regulatory pathways
• dc.subject.keyword European Union
• dc.subject.keyword United States
• dc.subject.keyword Healthcare innovation
• dc.subject.keyword Medical regulations
• dc.title Regulatory pathways and guidelines for nanotechnology-enabled health products: a comparative review of EU and US frameworks
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion