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Recentes
- 2025 AI Observatory report
- The EU new standard template covering recruitment and informed consent procedures.
- EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
- MEDTECH EUROPE : An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?
- European Data Protection Board public consultation on the draft Guidelines on the processing of personal data for scientific research
- Statistical Approaches to Establishing Bioequivalence
- Modelo de reporte trimestral de atividades de cultivo e fabrico de canábis para fins medicinais
- Content of Human Factors Information in Medical Device Marketing Submissions


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FDA welcomes comments on this draft guidance.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