FDA Data Standards Catalog

Recentes

• Advice on ‘end-of-year’ submission dates for type I variations in 2026
• EMA UPDATE : COMPLIANCE with EU GMP Annex 22 and Artificial Intelligence Standards
• FDA GUIDANCE DOCUMENT – E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification;
• The Council of the European Union has formally adopted the Pharmaceutical Package
• Sponsor Guidance: New Safety Module on the Annual Safety Report
• A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
• Electronic Submission Template for Premarket Approval Applications (PMAs)
• MDSAP Technical Review and Recognition Decision Procedure