FDA Data Standards Catalog

Recentes

• Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
• MDCG Position Paper: UDI assignment between manufacturers and distributors
• EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
• EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
• MHRA Updated guidance for the International Recognition Procedure (IRP)
• MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
• Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
• FDA Guidance for Drug Development