FDA Data Standards Catalog

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”