EMA on Friday released a new document summarizing the major and minor changes to the guidance:
News & Trends
Procurar
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- FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”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