News & Trends
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Recentes
- EU MDR Update: New Harmonised Standards for Medical Devices
- Clinical evidence for orphan in vitro diagnostic medical devices
- Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
- TEAM NB Code of Conduct for Notified Bodies vs 5.3
- GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
- New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
- AI in pharmacovigilance – EMA update
- Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”


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FDA welcomes comments on this draft guidance.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