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Recentes
- FDA Biosimilar Development – Q&A Guidance: Q&As on Biosimilar Development and the BPCI Act
- NDSG workplan 2026-2028 : Data and AI in medicines regulation
- New guidance on the conduct of clinical trials during public health emergencies
- Nova lei regula ensaios clínicos de medicamentos para uso humano em Portugal
- FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”
- webinar INTELIGÊNCIA ARTIFICIAL NA INDÚSTRIA FARMACÊUTICA :IA EM CONTEXTO GxP (Annex 11, 22, EU AI Act , GAMP®)
- GESTÃO da DISPONIBILIDADE do MEDICAMENTO: “Formação muito útil !
- IMDRF Playbook for Medical Device Regulatory Reliance Programs


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FDA welcomes comments on this draft guidance.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