Regulatory Rapporteur December 2025 – Contents
Regulatory Rapporteur
December 2025 | Vol. 22 | No. 11
Write to the Editor at publications@topra.org
The December issue of Regulatory Rapporteur focuses on North America.
Contents:
- Editorial: North America: Transparency, transformation and innovation pathways
- Focus: From laboratory to patient: The role of New Substance Notifications in delivering innovative therapies in Canada
- Focus: Cross-functional strategies in clinical data disclosure for EMA Policy 0070 and Health Canada PRCI
- Focus: A year of change for the US FDA: An update on notable pilots and programmes
- Standalone: Bringing innovation to market: Regulatory strategy for MedTech companies
- Standalone: Bridging the digital divide: A toolkit for equity-centred regulation of digital mental health
- Standalone: Medical device standards update
- Standalone: 2025 Regulatory Intelligence Conference Europe: Meeting report
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