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Monday, November 9, 2026
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Pharma
Manufacturing
R&D
Regulatory Affairs
Trials
Kazakhstan to undergo PIC/S on-site assessment in 2027
Regulatory Affairs
top-pharma
-
9 November 2026
Kazakhstan has been approved for an on-site assessment mission and an observed inspection in 2027 as part of its application for membership of the...
FDA proposes framework for individualized gene therapies as CMS expands access
Biotech
top-pharma
-
29 October 2026
The US Food and Drug Administration (FDA) has proposed a regulatory framework for individualized human genome editing therapies, while the Centers for Medicare &...
Clopidogrel oral liquids recall: assay control, OOS investigation and batch impact assessment
Inspection Insights
top-pharma
-
27 October 2026
UK announces AI Biosecurity Lab with up to £300 million in public and industry support
Pharma
top-pharma
-
25 October 2026
EMA opens consultations on confirmatory platform trials and pharmacovigilance data quality
Pharma
top-pharma
-
20 October 2026
AI in drug development: ten principles for data integrity, validation and lifecycle oversight
Documents
top-pharma
-
20 October 2026
PIC/S updates qualification and validation guidance: PI 006-4 now in force
Pharma
top-pharma
-
18 October 2026
FDA, Sanofi and Gilead discuss AI data readiness and risk-based validation
Manufacturing
top-pharma
-
20 September 2026
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