News & Trends
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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
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FDA welcomes comments on this draft guidance.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