News & Trends
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Recentes
- Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- AI Omnibus enters into force
- EU CTR Q&A Version 7.3 is Out
- New WHO guide on Artificial intelligence-related health research
- GDP for APIs: APIC Publishes Updated “How to Do” Document
- Team-NB Position Paper :TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES
- MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- New ISO Guidance for AI-Powered Medical Devices: ISO/TS 24971-2:2026 Published!


FDA issued a new guidance to help ensure that a device’s drug-delivery function consistently performs as intended including for prefilled syringes, injectors, nasal sprays, and inhalation devices: https://lnkd.in/eGd2hREH
FDA welcomes comments on this draft guidance. We encourage interested parties to submit comments by September 29, 2024, to ensure consideration before FDA begins work to finalize this guidance: https://lnkd.in/eXK4wRSa