UK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD GalleryUK | MHRA Sets Out Data Needs for Regulatory Decision-Making — HDRS Seen as Opportunity to Improve Regulatory Access to RWD
2026, EHDS, July 2026, Members-Only, Minor Update, RWD to Support Reg Decisions, Secondary Use of Existing Data, UK-
EU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical GalleryEU | Two Joint Clinical Assessments Discontinued After Dossiers Fail HTAR Requirements — Evidence Completeness, PICO Coverage and Reproducibility Become Critical
-
USA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework GalleryUSA | FDA Reissues Draft Guidance on Substantial Evidence of Effectiveness — Non-Interventional Studies Expressly Recognised Within the Adequate and Well-Controlled Investigation Framework
-
