Original ResearchPublished 18 September 2026Approval lag and loss for biologic-device combination products in Japan and the United StatesMakiko Mochizuki · Hideki MaedaFrontiers in Medical Technologydoi 10.3389/fmedt.2026.1924169
ReviewPublished 26 November 2025Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a reviewJoan D’souza · Mukesh Nandave · Ruth BlöchlingerFrontiers in Drug Safety and Regulationdoi 10.3389/fdsfr.2025.1609455
