USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information GalleryUSA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information
2026, January 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA-
- USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence Gallery
USA | FDA Approves Paediatric Rare Disease Treatment Supported by Real-World Evidence
2026, January 2026, Members-Only, Minor Update, Rare Diseases, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA -
- USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics Gallery
USA | FDA Removes Requirement for Identifiable Patient Data in Certain Medical Device RWE Submissions – Signals Potential Extension to Drugs and Biologics
2025, December 2025, Members-Only, Moderate Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, USA -
