Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review

This article captures the differences in regulations in post-marketing safety surveillance in drug device combinations in the US and the EU. Drug-device combinations have improved the landscape of health care through both drug effectiveness and personalized medicine. Regulatory frameworks in the U.S...

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Autores principales:	Joan D’souza, Mukesh Nandave, Ruth Blöchlinger
Formato:	Artigo
Lenguaje:	Inglês
Publicado:	Frontiers Media S.A. 2025-11-01
Colección:	Frontiers in Drug Safety and Regulation
Materias:	drug-device combination products postmarketing surveillance drug safety drug delivery systems regulatory harmonization pharmacovigilance
Acceso en línea:	https://www.frontiersin.org/articles/10.3389/fdsfr.2025.1609455/full
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