USA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation GalleryUSA | FDA Finalises Post-Approval Pregnancy Safety Studies Guidance — Strengthening Expectations for Pregnancy Registries, Complementary RWD Studies and Global Pregnancy Safety Evidence Generation
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USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance GalleryUSA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance
2026, March 2026, Members-Only, RWD to Support Reg Decisions, Secondary Use of Existing Data, Significant Update, USA-
- USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information Gallery
USA | FDA Issues Draft Guidance on Bayesian Methodology — Implications for Use of Real-World Data as External Information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 -
