FDA Data Standards Catalog

Recentes

• FDA Guidance for Drug Development
• Study supporting the monitoring of the availability of medical devices on the EU market. 2 July 2026
• IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
• GMP CANÁBIS 2026 : “Formação conduzida com profundo domínio teórico e prático “
• MHRA Open consultation Draft rare disease therapies regulatory framework
• EU Delegated Acts on Well-Established Technologies (WET) under the MDR
• CLINICAL TRIALS: EMA CTIS Sponsor Handbook
• Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples